FLEXIBLE CYSTOSCOPE, CHNL:7FR, 15FRX37CM

Additional Manufacturer Narrative

THE DEVICE WILL BE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UNSOLICITED. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).

Description of Event or Problem

REPORTED ISSUE: A PIECE OF THE DISTAL TIP OF A FLEXIBLE CYSTOSCOPE BROKE OFF FROM THE SCOPE WHILE IN USE ON A PATIENT AND HAD TO BE RETRIEVED. NO IMPACT TO THE PAITENT.

Additional Manufacturer Narrative

SHAFT NON-STORZ MATERIAL. VERTEBRAE NON-STORZ MATERIAL. NON-STORZ ANGLE COVER TORN 3MM FROM DISTAL TIP (LEAK). STAIN ON EYEPIECE. FOCUS RING FADED MARKINGS.MISSING THREAD WRAP AND DYMAX. NON STORZ DISTAL HEAD. MDR WAS SUBMITTED WITH INCORRECT MANUFACTURE ADDRESS SEE SECTION D3 AND G1 FOR CORRECTION. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).