Abstract

Text-Size + –

• Introduction:

  Flexible cystoscopes can be multi-use devices that visually inspect genitourinary structures such as the bladder and urethra. The objective of this study is to characterize the adverse events and associated device malfunctions of reusable flexible cystoscopes and to provide information on contamination and post-procedural infections.

  Materials and methods:

  The Manufacturer and User Facility Device Experience (MAUDE) database was queried for all adverse events and device malfunctions related to the use of flexible cystoscopes between January 2015 and December 2020. The MAUDE adverse event classification system was used to standardize the severity of complications and special focus was taken to identify clusters of events related to a single device.

  Results:

  A total of 335 adverse events related to flexible cystoscopes were identified. Most adverse events associated with patient harm were caused by infection (n = 121), which included 19 cases of sepsis, one ICU admission, and one death. Among the infections, 29 cases showed growth of the same organism in both the device and patient. There were five infectious outbreaks identified and each outbreak was attributed to a single cystoscope. Other adverse events included mechanical malfunction (n = 6) and allergic reaction (n = 1).

  Conclusions:

  Our findings highlight the risk of post-procedural infection associated with flexible cystoscope contamination. Further studies are needed to characterize the prevalence and incidence of flexible cystoscope contamination and to develop strategies to prevent post-procedural infection.