STONE CRUSHING FORCEPS, SGL. ACTION JAWS

Additional Manufacturer Narrative

DEVICE EVALUATION: THE DEVICE WAS SENT TO THE MANUFACTURER FOR INSPECTION. DURING THE MANUFACTURER'S TECHNICAL INSPECTION, THE ERROR DESCRIPTION PROVIDED BY THE CUSTOMER, "PIECE BROKEN OFF", COULD BE CONFIRMED. THE ATTACHMENT/CONNECTOR BETWEEN THE DRAWBAR AND THE MOVABLE JAW IS BROKEN. DUE TO THE AGE OF THE INSTRUMENT AND THE PRESUMED NUMBER OF TIMES IT HAS BEEN REPROCESSED, THIS CAN BE ATTRIBUTED TO WEAR AND TEAR OR USER ERROR. THE MATERIAL MAY HAVE BROKEN DUE TO EXCESSIVE FORCE, WHICH HAS ALTERED ITS PROPERTIES THROUGH USE AND CLEANING. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

Additional Manufacturer Narrative

THE DEVICE IN QUESTION WAS RETURNED TO THE MANUFACTURER. THIS INFORMATION IS REFLECTED IN SECTION D9. 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

ACCORDING TO THE INFORMATION RECEIVED, AFTER FIRST USE, THE JAWS WERE BROKEN EASILY. ACCORDING TO THE AVAILABLE PICTURE, THE PIN OF THE JOINT AND A PIECE NEAR THE PIN ARE BROKEN OFF. NO PATIENT INVOLVEMENT REPORTED. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.