FLEXIBLE CYSTOSCOPE, CHNL:7FR, 15FRX37CM

Additional Manufacturer Narrative

THE PRODUCT WAS NOT RETURNED FOR EVALUATION BY THE USER FACILITY, SIMED HEALTH UROLOGY IN (B)(6). SHOULD RELEVANT ADDITIONAL INFORMATION / THE INVESTIGATION RESULTS BECOME AVAILABLE, SUPPLEMENTAL MEDWATCH REPORT(S) WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE PRODUCT 11272CUK1 FLEXIBLE CYSTOSCOPE. ACCORDING TO MEDWATCH REPORT #MW5111792 RECEIVED FROM THE FDA, THE PATIENT REPORTED THE FOLLOWING: A STORZ FLEXIBLE CYSTOSCOPE WAS UTILIZED BY DR. (B)(6) AT (B)(6). CONSEQUENTLY I DEVELOPED A PSEUDOMONAS AERUGINOSA STRAINBACTERIAL UTI. I WAS HOSPITALIZED FOR THREE DAYS ON IV CIFEPRIME. I WAS ALLOWED TO GO HOME WITH A PICC LINE FOR 7 MORE DAYS OF CIFEPRIME INJECTIONS. THIS PROTOCOL HAS BEEN ORDERED FOR TEN DAYS TOTAL PENDING THAT MY LAND ARE CLEAR OF INFECTION. I NOTIFIED (B)(6) AND DR. (B)(6) NURSE ASSURES ME THAT SHE WILL OBTAIN THE MODEL NUMBER FOR ME BY THE END OF MONDAY, (B)(6). I WILL THEN SEND THAT NUMBER IN TO THIS SITE. SHE IS AWARE I AM MAKING THIS REPORT TO YOU AND STATED THAT THIS WAS A NECESSARY STEP SO IT HELPS IN PREVENTION GOING FORWARD. SHE WAS GOING TO RELAY THE INFORMATION TO DR. A SUBSEQUENT MEDWATCH REPORT, #MW5112004, FOR THE SAME EVENT WAS RECEIVED FROM THE FDA, WHICH STATES: PSEUDOMONAS INFECTION AFTER CYSTOSCOPE EXAM T SYMED, (B)(6) WHICH RESULTED IN HOSPITALIZATION AT SHANE'S HOSPITAL FOR 3 DAYS WITH IV OF CIPREMIN FOLLOWED BY 7 DAYS OF PICC LINE TREATMENT WITH HOME HEALTH. OUR INVESTIGATION TO-DATE HAS CONFIRMED THAT BOTH MEDWATCHES RECEIVED ARE REPORTING THE SAME EVENT. THE ADVERSE EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).