RESECTOSCOPE SHEATH 9FR

Additional Manufacturer Narrative

BASED ON THE DAMAGE FOUND THE CERAMIC INSERT BROKEN OFF/BROKEN OUT AT THE DISTAL END, THE BREAKAGE OF THE CERAMIC BEAK MAY HAVE BEEN CAUSED BY PULLING THE INNER SHAFT OUT OF THE OUTER SHAFT AT AN ANGLE. WHEN THE INNER SHAFT IS PULLED OUT OF THE OUTER SHAFT AT AN ANGLE THIS PRESSES THE CERAMIC AGAINST THE OUTER SHAFT AND CAN CAUSE IT TO BREAK. IN ADDITION, THE IFU POINTS OUT THAT THE CERAMIC BEAK SHOULD BE CHECKED FOR DAMAGE BEFORE USE. MOST PROBABLE THE ROOT CAUSE OF THE DESCRIBED FAILURE IS USAGE-RELATED. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE PRODUCT 27033R RESECTOSCOPE SHEATH 9 FR. ACCORDING TO THE INFORMATION RECEIVED A PIECE OF THE RESECTOSCOPE BROKE OFF IN PATIENT WHILE UNDERGOING A TRANSURETHRAL RESECTION OF URETHRAL VALVES. AFTER 40-45 MINUTES ATTEMPTS WERE MADE TO RETRIEVE, THE PIECE WAS EVENTUALLY REMOVED. A FOLEY CATHETER WAS LEFT INDWELLING TO PREVENT CLOT FORMATION AND POTENTIAL URINARY RETENTION.

Additional Manufacturer Narrative

INITIAL EVALUATION FINDINGS FOUND A BROKEN CERAMIC TIP WITH BUBBLING EPOXY. THE LOT CODE OF 10/2016 IS OVER THE MANUFACTURERS WARRANTY PERIOD AND IS OVER 7 YEARS OLD WITH SIGNS OF USE. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID (B)(4). THERE ARE NO OTHER SIMILAR COMPLAINTS FILED IN THE SAME TIME PERIOD. THE IFU STATES WARNING: SHEATHS WITH CERAMIC TIPS MUST BE HANDLED CAREFULLY. THE SHEATHS MUST BE CHECKED FOR CRACKS OR OTHER DAMAGE EACH TIME THEY ARE USED. DAMAGED SHEATHS (CHIPS OR CRACKS) MUST NEVER BE USED, SINCE MALFUNCTIONS COULD OCCUR WHICH COULD LEAD TO PATIENT INJURY. ONLY USE OBTURATORS SPECIALLY DESIGNATED FOR SHEATHS WITH CERAMIC IPS. UNSUITABLE OBTURATORS MAY CAUSE DAMAGE TO THE CERAMIC TIP.