INNER SHEATH FOR 27050 SC

Additional Manufacturer Narrative

ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION AND TO HAVE DEVICE RETURNED FOR EVALUATION; HOWEVER, THERE HAS BEEN NO RESPONSE FROM THE REPORTER AT THE TIME OF THIS REPORT. ONCE THE EVALUATION IS COMPLETED OR IF NEW INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WOULD BE MADE TO THE FDA. THIS COMPLAINT WILL BE TRACKED AND TRENDED. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT THE TIP OF INNER SHEATH BROKE OFF DURING SURGERY. THE SURGEON COULD NOT RETRIEVE THE BROKEN PIECE BECAUSE THE BROKEN PIECE COULD NOT BE VISUALIZED ON THE MONITOR. NO ADDITIONAL INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

PER EVALUATION FINDINGS BY THE MANUFACTURING SITE: THE CONCERNED PRODUCT WAS NOT RETURNED BY THE CUSTOMER. THEREFORE, A PHYSICAL INVESTIGATION WAS NOT POSSIBLE, AND THE INVESTIGATION WAS CONDUCTED BASED ON THE AVAILABLE INFORMATION. THE RECEIVED INFORMATION INDICATES THAT THE CERAMIC BEAK BROKE DURING THE PROCEDURE AND A PART FELL INTO THE PATIENT AND HAS NOT BEEN FOUND. POTENTIAL SCENARIOS LEADING TO THIS COULD BE FOR EXAMPLE THAT THE TIP WAS STRUCK, WHICH CAN LEAD TO BREAKAGE, OR THE MATERIAL WAS DAMAGED BY THERMAL IMPACT (THE ELECTRODE BURNS NEAR THE CERAMIC INSERT). AN APPLICATION ERROR IS ASSUMED AS THE MOST PROBABLE CAUSE. THE INSTRUCTIONS FOR USE POINT OUT THAT THE PRODUCT SHOULD BE CHECKED BEFORE AND AFTER EVERY USE FOR FUNCTIONALITY, DAMAGE, CHANGES TO THE SURFACE, COMPLETENESS AND CORRECT ASSEMBLY. IT IS FURTHERMORE STATED TO NOT CONTINUE TO USE DAMAGED PRODUCTS AND NOT TO LEAVE BROKEN-OFF COMPONENTS INSIDE THE PATIENT. IN ADDITION, THE INSTRUCTIONS STATE TO NOT OVERLOAD THE PRODUCT WITH MECHANICAL STRESS. CONCERNING THE CERAMIC COMPONENTS, IT IS STATED TO HANDLE PRODUCTS WITH CERAMIC COMPONENTS CAREFULLY AND TO CHECK THE CERAMIC COMPONENTS FOR DAMAGE (E.G., CRACKS CHIPS) BEFORE EACH USE. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID (B)(4).