ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR

Additional Manufacturer Narrative

DEVICE EVALUATION: THE EVALUATION WAS COMPLETED ON 01/20/2026. THE AFFECTED ELECTRODES WERE RETURNED FOR INVESTIGATION. THE COMPLAINT "BROKE DURING PROCEDURE" CAN BE CONFIRMED. ALL THREE ELECTRODES SHOW BROKEN SURFACES WITH A DUCTILE APPEARANCE (SIGN OF A BREAK BY FORCE), PARTIAL CREATING AN SHORTCUT RESULTING IN MOLTEN AREAS. THE MOST PROBABLE ROOT CAUSE IS MECHANICAL DAMAGE DUE TO OVERLOADING THE ELECTRODE DURING APPLICATION. THE CORRESPONDING IFU 97000160 V10.5/06/2024 ALREADY CONTAINS A WARNING NOT TO OVERLOAD THE DEVICE ON PAGE 5: WARNING: RISK OF INJURY: OVERLOADING THE INSTRUMENT BY EXERTING TOO MUCH FORCE MAY CAUSE THE MEDICAL DEVICE TO BREAK, BEND, AND MALFUNCTION, AND CONSEQUENTLY INJURE THE PATIENT OR USER. DO NOT OVERLOAD THE INSTRUMENTS. DO NOT BEND BENT INSTRUMENTS BACK TO THEIR ORIGINAL POSITION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT DURING A TURP 3 X BIPOLAR LOOPS BROKE WHILST IN USE WITHIN THE PATIENT, WITH ALL 3 FROM THE SAME BATCH NUMBER. ALL PARTS WERE RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO HARM TO THE PATIENT, USER OR THIRD IS REPORTED.

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).