FORCEPS,OPTICAL,GRASPING

Additional Manufacturer Narrative

THE INTERNAL INVESTIGATION SHOWS NO INDICATION FOR A MATERIAL OR MANUFACTURING RELATED ISSUE. THE DEVICE WAS RETURNED ON 14.09.2021 TO THE MANUFACTURE FOR INVESTIGATION. UPON THE EVALUATION, IT COULD BE CONFIRMED THAT THE GRASPING FORCEPS BROKE DISTALLY INTO SEVERAL PARTS IN THE AREA OF THE JOINT. ALSO, STRONG DEFORMATIONS CAN BE SEEN AT THE RIVETED POINTS, WHICH INDICATES THAT A HIGH LEVEL OF FORCE HAS BEEN APPLIED, I.E. USER ERROR. A WARNING TO NOT OVERLOAD THE DEVICE BY EXERTING TOO MUCH FORCE AND TO NEVER BEND BACK THE DEVICE INTO SHAPE BY USER WAS ALREADY INCLUDED IN THE RELATED IFU. ALTHOUGH IT WAS REPORTED, THAT 3 METAL PARTICLES FELL INTO THE PATEINT´S BLADDER, WHICH CAUSED AN OPERATION EXTENSION OF 30 MINS, DUE TO THE FACT, THAT THE INCIDENT WAS DETERMINED TO BE CAUSED BY AN OPERATOR ERROR AND NO INJURY TO PATIENT, USER OR THIRD OCCURRED. FURTHERMORE, THE SEVERITY OF THE POTENTIAL HARM IS ASSESED AS REVERSIBLE IN THE RELATED RISK FILE AND THE RISK OF OCCURRENCE IS RATED AS NEGLIGIBLE, AS THE EVENT DID NOT AND MIGHT NOT LEAD TO DEATH OR SERIOUS DETERIORATION IN THE STATE OF HEALTH. IN ADDITION, ACCORDING TO THE COMPLAINT ANALYSIS NO SERIOUS INJURIES WERE REPORTED IN RELATION TO THE DESCRIBED ISSUE.

Additional Manufacturer Narrative

DEVICE HAS NOT YET RETURNED TO THE FACTORY.

Description of Event or Problem

AS PER A MANUFACTURER INCIDENT REPORT WE RECEIVED FROM THE FACTORY IN (B)(6): AS REPORTED: DURING A REMOVAL OF A BLADDER STONE, A SCREW BROKE OFF AND 3 METAL PARTICLES FELL IN THE BLADDER DUE TO WHICH THEY WERE LABORIOUSLY REMOVED. THE SURGERY TIME WAS EXTENDED BY 30 MINUTES.