STONE CRUSHING FORCEPS, SGL. ACTION JAWS

Additional Manufacturer Narrative

THE REPORTED DEVICE IS PENDING TO RETURN FOR EVALUATION. ONCE THE REPORTED DEVICE IS RETURNED AND EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WOULD BE MADE TO THE FDA. THIS COMPLAINT WILL BE TRACKED AND TRENDED. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT THE STONE CRUSHING FORCEPS' TIP WOULD NOT CLOSE DURING CYSTOSCOPY AND CYSTOLITHOPAXY PROCEDURES. DURING THE PROCEDURE, THE SURGEON ATTEMPTED TO REMOVE BLADDER STONE BY USING STONE CRUSHING FORCEPS; HOWEVER, THE FORCEPS MALFUNCTIONED WHILE INSIDE THE PATIENT. THE SURGEON COULD NOT REMOVE THE FORCEPS SAFELY FROM INSIDE OF THE PATIENT; THUS, APERINEAL URETHROTOMY IN THE PENILE URETHRA WAS PERFORMED TO REMOVE THE FORCEPS. IT WAS NOTED THAT THERE WAS NO ISSUE WITH THE FORCEPS PRIOR. THE BLADDER STONE DID NOT REQUIRE TO UTILIZE MORE FORCES THAN USUAL TO CRUSH. IT WAS CONFIRMED NOTHING WAS LEFT INSIDE OF THE PATIENT.

Additional Manufacturer Narrative

PER INVESTIGATION BY THE MANUFACTURING SITE: DATE OF INVESTIGATION: MAY-28-2024. RESULT OF INVESTIGATION: THE ITEM WAS NOT RETURNED TO KARL STORZ TUTTLINGEN, THEREFORE NO PHYSICAL INSPECTION OF THE ITEM COULD BE PERFORMED. ACCORDING TO THE DOCTOR'S DESCRIPTION OF THE FAULT, IT WAS MOST PROBABLY DAMAGED BY IMPROPER USE. AN IMPACT ON THE MOVABLE JAW SECTION CAUSED BY IMPROPER HANDLING CAN RESULT IN THE MOVABLE JAW SECTION NO LONGER CLOSING. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).