Texas Cystoscopy Infection Lawsuit

Cystoscopes are medical scopes that are used in urology procedures. If they are not adequately sanitized between patients, they can transmit bacteria and lead to serious infection outbreaks.

Need a Texas Cystoscopy Infection Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you got a urinary tract infection or sepsis after a bladder scope procedure involving a reusable cystoscope, contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.

Quick Facts About Contaminated Cystoscopes

Procedure: Cystoscopy, a medical procedure where a reusable scope is passed through the urethra to examine the bladder
Infection reports in published research: 121 infection reports involving flexible cystoscopes between 2015 and 2020, including 19 cases of sepsis and 1 death
Device-to-patient matches: 29 reports in which the same organism grew in both the cystoscope and the patient
Outbreaks: A study in 2022 identified 5 outbreaks of infections linked to flexible cystoscopes between January 2015 and December 2020. Among the infections, 29 cases showed growth of the same organism in both the device and patient.
Federal reports: The FDA received over 450 reports of post-procedure infection or contaminated urological endoscopes between January 2017 and February 2021
Karl Storz recall: The Urgent Medical Device Recall in April 2022 involved around 30 models of flexible urological endoscopes, with high-level disinfection discontinued entirely
Olympus recall: MAJ-891 Forceps/Irrigation Plug, 120 injuries and 1 death from infection, identified by the FDA as its most serious type of recall

Study Investigates Infection Outbreaks From Contaminated Cystoscopes

A study published in the Canadian Journal of Urology in 2022 identified a total of 335 adverse event reports that were filed with the FDA between January 2015 and December 2020 involving cystoscope infections and persistent contamination.

These reports included serious injuries, such as:

121 reports of patients who suffered infections, which was the most common type of patient injury in the dataset
19 cases of sepsis
1 intensive care admission and 1 patient death
29 reports where the same organism was detected on the scope and in the patient who was infected
5 outbreaks, each tracked back to one specific cystoscope
6 mechanical malfunctions and 1 allergic reaction

What Is the Infection Risk After a Cystoscopy?

Flexible cystoscopes are reusable medical devices that are can transmit biological matierial from one patient to another if they are not properly cleaned and sterilized. The cleaning or “reprocessing” phase is a multi-step procedure that health care facilities must follow exactly. It involves pre-cleaning, a leak test, manual scrubbing, and then disinfection or sterilization. The problem is that scopes often have complex designs with narrow channels, nooks, and crannies that can be difficult to sterilize every time.

What is the Risk?

Urinary tract infection, including recurrent and antibiotic-resistant UTI
Pseudomonas aeruginosa
E. coli
Carbapenem-resistant Enterobacterales (CRE), a drug-resistant “superbug”
Bacteremia and bloodstream infection
Urosepsis, sepsis, and septic shock
Pyelonephritis and kidney damage
Prostatitis and epididymitis

Karl Storz Recalled Urological Scopes After Its Cleaning Method Failed

In April 2022, Karl Storz issued a recall for roughly 30 models of flexible urological endoscopes, including cystoscopes and cystourethroscopes. The company also told healthcare facilities to stop using high-level disinfection on the scopes, and sterilize them after every use.

The recall was announced after the FDA asked Karl Storz to test a sample of flexible urological endoscopes to confirm that its own reprocessing instructions actually worked. Instead, the tests identified reprocessing failures associated with high-level disinfection.

FDA Linked a Reported Death to an Olympus Cystoscope Accessory

INOlympus made a small reusable part called the MAJ-891 Forceps/Irrigation Plug that attaches to the working channel of certain scopes. In December 2024, the company told customers to take it out of service, and the FDA identified the recall as its most serious type.

The harm count Olympus handed regulators was 120 injuries and one death, and the fatal case came out of a bladder scope procedure. Olympus had already pulled the part from the U.S. market back in 2022, but that did not get it out of clinics. The MAJ-891 is reusable rather than disposable, so a practice that bought one earlier had no reason to throw it away.

Three reports of patient death involving urological endoscopes have reached the FDA, all of them from outside the United States. In one, the scope had already flunked a leak test, the check that reveals a breach in the device where fluid and bacteria can get inside.

Which Cystoscopes May Be Affected?

Olympus MAJ-891 Forceps/Irrigation Plug, all lots, UDI 04953170063114
Olympus CYF series flexible cystoscopes and cysto-nephroscopes, including the CYF-240, CYF-5, CYF-5R, CYF-V2, CYF-VA2, CYF-VH, and CYF-VHR
Olympus VISERA Cysto-Nephro Videoscope ENF-V2, named in the FDA’s June 2025 import alert
Karl Storz single channel flexible cystoscopes, cystourethroscopes, ureteroscopes, and ureterorenoscopes covered by the April 2022 recall
And more

Do I Have a Lawsuit?

Our law firm is reviewing cases for Texans who had any of the following endoscopic procedures from 2018 to the present day:

Cystoscopy
Ureteroscopy
Hysteroscopy
Laparoscopy
Colonoscopy
ERCP
Bronchoscopy
Upper Endoscopy
Sinus Endoscopy

You or your loved one must also have suffered at least one of the following serious injuries as a result of the procedure:

Diagnosis of a “superbug” infection, such as a drug-resistant infection like CRE or E. coli, within 180 days of the procedure
Organ or tissue damage, or perforation
Dislodging or breaking of the endoscopic device
Severe bleeding or hemorrhaging that required hospitalization or a blood transfusion
Sepsis or bacteremia (blood infection)
Bacterial infection requiring hospitalization
Pneumonia or severe pulmonary infection
Tuberculosis within 90 days of the procedure
HIV diagnosis within 90 days of the procedure
Death from an infection, a “superbug,” or a component failure

Related Scope Infection Investigations

Cystoscopy is one of several procedures under review. Our firm is also investigating claims involving contaminated scopes used in other parts of the body. These medical devices are described on our Texas endoscope infection lawsuit page.

Need a Texas Cystoscopy Infection Lawsuit?

Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.

Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”

The Clark Firm has assembled a team of trial lawyers with more than 100 years of experience, participation in over 600 jury trials, and $260 million in verdicts and/or settlements. Please use the form below to contact our law firm for a free case review.