UROLOGY INNER SHEATH

Additional Manufacturer Narrative

PER MANUFACTURING EVALUATION: ACCORDING TO THE CUSTOMER, THE CERAMIC BEAK WAS BROKEN DURING THE PROCEDURE. IT IS VERY LIKELY THAT THE ARTICLE SHOWS DAMAGE TO THE SHAFT DUE TO USE SIGNS. IN ADDITION, THE DAMAGE MAY HAVE BEEN CAUSED BY EXCESSIVE FORCE DURING USE OR SIGNS OF WEAR AND TEAR. IN THIS CONTEXT, THE IFU POINTS OUT THAT DAMAGE TO THE SHAFT MAY HAVE A NEGATIVE EFFECT ON THE CERAMIC BEAK. THEREFORE, IT IS POINTED OUT IN THE INSTRUCTIONS FOR USE THAT YOU SHOULD CHECK THE CERAMIC COMPONENTS FOR DAMAGE SUCH AS CRACKS, CHIPPING, ETC. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS A MALFUNCTION WITH A 27050CA INNER SHEATH FOR 27050SC. ACCORDING TO THE INFORMATION RECEIVED, THE CERAMIC BEAK BROKE INSIDE PATIENTS BLADDER DURING A TURP PROCEDURE. THE PIECE/PIECES WERE ABLE TO BE REMOVED WITH NO DIRECT HARM TO PATIENT, HOWEVER; AN ADDITIONAL 30 MINUTES OF ANESTHESIA WAS ADDED TO THE PROCEDURE. IT WAS NOTED THE POSSIBILITY OF A 3RD PARTY REPAIR WAS OBSERVED BY (B)(6).

Additional Manufacturer Narrative

MANUFACTURING SITE EVALUATION: THE CERAMIC DISTAL TIP IS BROKEN/FRACTURED WITH REMAINING ATTACHED BEAK HAVING SHARP, JAGGED EDGE. LOT CODE IS TQ 06((06/2019). SHOULD RELEVANT ADDITIONAL INFORMATION/INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UNSOLICITED. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID (B)(4).