OBJECTIVES

: Cystoscopy is considered a safe and the most concerning and prevalent disadvantage of cystoscopy is the risk of urinary tract infection. Each year, several Manufacturer and User Facility Device Experience (MAUDE) reports are declared to the U.S. Food and Drug Administration (FDA) containing data on suspected device-associated deaths, serious injuries, and malfunctions. This study aimed to identify the most common device-associated adverse events following cystoscopy.

METHODS

: All MAUDE reports from January 1, 2010 to May 4, 2020 within the product class ‘Cystoscope and Accessories, Flexible/Rigid’ was extracted and analyzed. Reports were thematized and coded into following categories: patient infection (post-procedural), scope malfunction, positive microbiological test and image defects. Reports not covered by the categories were excluded. Reports categorized as ‘positive microbiological test’ were coded to identify bacterial species and CFU-levels associated with positive microbiological tests described in the reports.

RESULTS

: Of the 393 reports, 18 reports were not covered by the identified categories and thereby excluded. Of the remaining 375 reports, 188 (50 %) reported on patient infection, 94 (25 %) reported on positive microbiological test, 84 (22.5 %) reported on scope malfunctions and 9 (2.5 %) reported on image defects. Among positive microbiological test reports, 73 (78 %) stated the CFU-level revealing that 23 (32%) of the tests contained unacceptable CFU-levels (above 25 CFU/scope, 10 CFU/mL or 10 CFU/channel). 44 (47 %) reports on microbiological tests included information on bacterial species whereas 42 reportedly contained uropathogenic bacteria.

CONCLUSIONS

: The MAUDE reports for cystoscopes indicate, that the most common adverse event is patient infections or positive microbiological tests of cystoscopes. A third of the positive microbiological tests contained CFU-levels exceeding acceptance criteria. Patient infections are associated with higher morbidity in patients and increased cost for the healthcare system. The results underline the importance of identifying and eliminating causes of infections following cystoscopy.