ELECTRODE, BIPOLAR

Additional Manufacturer Narrative

CORRECTION: CREATED CORRECTION TO MODIFY FROM MALFUNCTION TO ADVERSE EVENT. UPDATED THE FOLLOWING SECTIONS: B1 - SELECTED ADVERSE EVENT AND PRODUCT PROBLEM. B2 - SELECTED REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. H1 - SELECTED SERIOUS INJURY. H2 - SELECTED CORRECTION.

Additional Manufacturer Narrative

THE DEVICE 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).

Description of Event or Problem

DURING A PROSTATE RESECTION USING THE THULEP TECHNIQUE AND THE SPECIFIC BIPOLAR RESECTION LOOP, THE LOOP BROKE INSIDE THE PATIENT WHEN THE SURGEON ATTEMPTED TO RETRIEVE A PROSTATE CHIP. THE SURGEON THEN HAD TO RECOVER THE SMALL BROKEN FRAGMENT USING A SINGLE USE FLEXIBLE FOREIGN BODY FORCEPS.