FLEXIBLE CYSTOSCOPE, CHNL:7FR, 15FRX37CM

Additional Manufacturer Narrative

THE PRODUCT WAS RETURNED TO THE MANUFACTURING SITE IN (B)(4) AND HAS BEEN FORWARDED TO THE FACTORY IN (B)(6) FOR INVESTIGATION. 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 THE INFORMATION RECEIVED, THE CUSTOMER IS COMPLAINING THAT THIS SCOPE IN PARTICULAR IS CAUSING INFECTIONS. THEY HAVE TRACED BACK APPROXIMATELY 7 INFECTIONS, AND THE COMMON THEME IS THE USE OF THIS SCOPE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED AS OF THE DATE OF THIS REPORT. THIS REPORT IS FOR THE CASE #1 OF THE OF SEVEN CASES. THE ADVERSE EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).

Additional Manufacturer Narrative

THE SUBJECT CYSTO-URETHROSCOPE WAS SENT OUT FOR EXTERNAL LAB TESTING. THE MICROBIOLOGICAL STATUS OF THE SCOPE WAS EVALUATED BEFORE, AND AFTER, A MANUAL CLEANING AND DISINFECTION PROCEDURE: BEFORE MANUAL CLEANING AND DISINFECTION: PSEUDOMONAS WAS DETECTED AFTER PROCESSING: NO PSEUDOMONAS; NO MICROBIOLOGICAL OBJECTION (LIMIT: >1CFU/ML) BASED ON EXTERNAL LAB TESTING, IT HAS BEEN CONCLUDED THAT THE PRODUCT IS STERILE WHEN REPROCESSING IS PERFORMED PER IFU INSTRUCTION.