STONE CRUSHING FORCEPS, SGL. ACTION JAWS

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 STONE CRUSHING FORCEPS WOULD NOT CLOSE AFTER A STONE WAS LODGED INSIDE THE JAWS. THIS MEANT THAT THE INSTRUMENT COULDN'T BE REMOVED FROM THE SHEATH DURING A CYSTOSCOPY. THE SURGEON HAD TO REVERT TO AN OPEN PROCEDURE TO FREE THE STONE FROM THE INSTRUMENT SO THAT IT COULD BE SAFELY PASSED BACK THROUGH THE CYSTOSCOPY SHEATHS.

Additional Manufacturer Narrative

RESULT OF INVESTIGATION: IN THIS CASE, AN APPLICATION ERROR MUST BE ASSUMED. BASED ON THE CUSTOMER'S DESCRIPTION "A STONE CRUSHING FORCEPS WOULDN'T CLOSE AFTER A STONE WAS LODGED INSIDE THE JAWS", IT CAN BE ASSUMED THAT THE STONE WAS CAUGHT IN THE REAR AREA OF THE TONGS AND BECAME WEDGED IN THE TEETH OF THE TONGS, MAKING IT IMPOSSIBLE TO OPEN AND CLOSE. THE EXCESSIVE FORCE MAY HAVE CAUSED THE MATERIAL OF THE PULL ROD TO "STRETCH". MATERIAL FATIGUE MAY ALSO OCCUR DUE TO THE AGE OF THE MATERIALS. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

Additional Manufacturer Narrative

ADDITIONAL INFORMATION IS PROVIDED IN SECTION D9 TO REFLECT THAT THE PRODUCT WAS RETURNED FOR EVALUATION. THE ITEM IN QUESTION WAS RETURNED TO THE MANUFACTURER. THE INVESTIGATION IS NOT COMPLETED YET. THE INVESTIGATION RESULTS ARE PENDING. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).