ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR

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 A BIPOLAR LOOP BROKE SPONTANEOUSLY DURING AN OPERATIVE PROCEDURE. THE BROKEN PIECE IN THE BLADDER WAS REMOVED. DELAY PROCEDURE, NEW LOOP USED FOR THE CONTINUATION OF THE SURGICAL PROCEDURE. NO INFORMATION ON LENGTH OF SURGICAL DELAY OR PROLONGATION OF SURGERY. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT INJURY OR HARM REPORTED. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED. THEREFORE, THIS CASE IS NOT REPORTABLE IN FRANCE.

Additional Manufacturer Narrative

ALTHOUGH THE PRODUCT WAS NOT RETURNED, A VISUAL INSPECTION OF SIMILAR REPORTED CASES WAS CONDUCTED. IN THESE CASES, THE FRACTURE SURFACES EXHIBITED DUCTILE CHARACTERISTICS, INDICATING BREAKAGE DUE TO MECHANICAL FORCE. ADDITIONALLY, OBSERVABLE BENDING OF THE ELECTRODE SUGGESTS THAT EXCESSIVE FORCE WAS APPLIED, LIKELY DURING HANDLING OR CLINICAL USE. SUCH FORCE CAN OCCUR IN SCENARIOS INCLUDING: HIGH TENSILE STRESS WITHOUT PROPER HF CURRENT ACTIVATION, IMPROPER INSERTION TECHNIQUE OR RESISTANCE MET DURING RESECTION, EXCESSIVE LATERAL PRESSURE APPLIED DURING USE. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).