FLEXIBLE CYSTOSCOPE, CHNL:7FR, 15FRX37CM
Received Jun 9, 2022
Report 1221826-2022-00084 · MDR key 14643663
Device
Generic name
Flexible Cystoscope
Manufacturer
Karl Storz EndovisionModel number
11272CUK1Catalog number
11272CUK1
Product problems
- Contamination /Decontamination Problem
- Contamination /Decontamination Problem
Patient
Unknown
- Unspecified Infection
- Unspecified Infection
Narrative
Description of Event or Problem
TWO FLEXIBLE CYSTOSCOPES WERE USED IN CASES BACK IN (B)(6) 2021 AND POSSIBLY EARLY (B)(6)2021, AND THE FACILITY BELIEVES THEY MAY BE PASSING INFECTIONS TO THE PATIENTS. CUSTOMER BELIEVES THAT 5 TO 7 PATIENTS CONTRACTED AN INFECTION BUT WAS UNABLE TO VERIFY EXACT QUANTITY OF PATIENT INFECTIONS. CUSTOMER RETURNED TWO DIFFERENT MODEL CYSTOSCOPES THAT THEY BELIEVED WERE INVOLVED IN THE CASES, MODEL #'S 11272CUK1 AND 11272CK2, AND WE PREVIOUSLY SUBMITTED TWO REPORTS, ONE FOR EACH MODEL (REPORT #1221826-2021-00051 AND REPORT #1221826-2021-00054) . THIS REPORT IS FOR THE CASE #3 OF THE OF SEVEN CASES.
Additional Manufacturer Narrative
THE EVALUATION FOUND AN OVERBEND IN THE PROXIMAL SHAFT; THE CHANNEL WALL WAS LIFTED, NO LEAK; DEBRIS WAS FOUND ON THE VERTEBRAE; AND BROKEN IMAGE AND LIGHT FIBERS. OUR FIELD SERVICE SPECIALIST PERFORMED AN IN-SERVICE AND FOUND SEVERAL AREAS FOR PROCESS IMPROVEMENTS WITHIN THE FACILITY THAT WILL HELP THEM WITH INFECTION CONTROL IN THE FUTURE.