ELECTRODE, UNIPOLAR, POINTED

Additional Manufacturer Narrative

UPON ANALYSIS DURING MANUFACTURING, IT WAS DISCOVERED THAT THE CUTTING WIRE OF THE RETURNED DEVICE HAD SEPARATED AT THE TIP, WITH MOLTEN AREAS EVIDENT ON BOTH SIDES OF THE SEPARATION. ALTHOUGH THE ELECTRODE TIP SHOWED MELTING ON BOTH SIDES OF THE SEPARATION WITHOUT ANY ABRASION, OVERHEATING IS LIKELY THE CAUSE. THIS OVERHEATING COULD HAVE OCCURRED DUE TO VARIOUS FACTORS, SUCH AS ACCIDENTAL CONTACT WITH ANOTHER INSTRUMENT CAUSING A SHORTCUT, PROLONGED OPERATION WITHOUT ADEQUATE COOLING TIME, OR SELECTING TOO HIGH A VOLTAGE ON THE HF GENERATOR. IT'S IMPORTANT TO NOTE THAT THE CORRESPONDING INSTRUCTION FOR USE (IFU 97000160_V 10.4) ALREADY INCLUDES A VOLTAGE LIMITATION TO PREVENT THERMAL OVERLOAD. FURTHERMORE, THE IFU EMPHASIZES THAT USING DEVICE SETTINGS EXCEEDING THE SPECIFIED VALUES CAN LEAD TO DAMAGE TO THE INSTRUMENT. THERE HAVE BEEN NO REPORTS OF PATIENT HARM OR INJURY ASSOCIATED WITH THIS ISSUE. THE BROKEN PART WAS RETRIEVED WITHOUT ANY HARM TO THE PATIENT, THEREFORE THIS CASE IS NON-REPORTABLE IN UNITED KINGDOM. INTERNAL KARL STORZ REFERENCE NUMBER: (B)(4).

Additional Manufacturer Narrative

THE ITEM 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).

Additional Manufacturer Narrative

THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. DEVICE WAS NOT YET RETURNED FOR INVESTIGATION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT WHILE CONDUCTING THE TRANSURETHRAL INCISION OF THE BLADDER NECK, THE SURGEON NOTICED THE COLLINS KNIFE TIP HAD SPLIT. SURGEON INFORMED SCRUB NURSE TO EXCHANGE THE COLLINS KNIFE AND PROCEEDED WITH THE OPERATION.