CYSTO-URETHRO-FIBERSCOPE

Additional Manufacturer Narrative

DEVICE EVALUATION: THE DEVICE IN QUESTION (11272C1 CYSTO-URETHRO-FIBERSCOPE, SERIALNUMBER: (B)(6), MANUFACTURED 18-MARCH-2024) WAS RECEIVED BY THE MANUFACTURING SITE IN GERMANY FOR INVESTIGATION ON 10-OCT-2025. INVESTIGATION OF THE DEVICE REVEALED THAT THE SHEATHING OF THE SHAFT IS BRITTLE AND TORN AND THE HOUSING AND THE HANDLE SHOW SLIGHT SIGNS OF WEAR. ACCORDING TO THE PRODUCT HISTORY REVIEW THE DEVICE WAS NOT REPAIRED OR MAINTAINED UNTIL TODAY. QUALITY TEST WAS PASSED AT THE TIME OF DELIVERY. IN THE PAST, A REPROCESSING AND INFORMATION CHECKLIST PROVIDED BY THE CUSTOMER WAS EVALUATED FOR SIMILAR COMPLAINTS WITH SIMILAR FAILURE DESCRIPTION. THE REASON FOR THE BURST OF THE SHAFT, IN EARLIER SIMILAR DOMPLAINTS, WAS DUE TO NON-COMPLIANT REPROCESSING. ACCORDING TO THE INVESTIGATION THE FAILURE CAN BE TRACED BACK TO A REPROCESSING FAILURE. THE ABOVE CONDUCTED INVESTIGATIONS DID NOT REVEAL A ROOT CAUSE RELATED TO THE LABELLING, THE DEVICE OR ITS HISTORY. ALL PRODUCTION RELATED QUALITY CHECKS WERE PASSED, AND NO NON-CONFORMITIES WERE IDENTIFIED IN THE DEVICES MANUFACTURING RECORDS. CORRECTION TO COMPLAINT ID AS IT WAS INITIALLY SUBMITTED WITH THE INCORRECT CASE NUMBER. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

Description of Event or Problem

IT WAS REPORTED THE SHEATH OF THE DEVICE BROKE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

Additional Manufacturer Narrative

THE DEVICE IN QUESTION WAS RETURNED TO THE MANUFACTURER. THE EVALUATION IS ANTICIPATED, BUT NOT YET BEGUN. THE INVESTIGATION WILL BE PERFORMED BY A DESIGNATED KARL STORZ EMPLOYEE. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).