GRASPING FORCEPS, 3 FR.

Description of Event or Problem

IT WAS REPORTED THAT PROBLEM THE JAWS OF THE GRASPER BROKE OFF INSIDE THE PATIENT. THE BROKEN FOREIGN BODY WAS REMOVED WITH ANOTHER GRASPER AND ALL PIECES WERE CONFIRMED REMOVED FROM THE PATIENT. STAFF ALSO REPORTED THAT THE GRASPER OFTEN DOES NOT OPEN WHEN TRIGGERED BY THE PROCEDURALS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT DELAY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

Additional Manufacturer Narrative

THE DEVICE IS NOT EXPECTED TO BE RETURNED. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UNSOLICITED. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).

Additional Manufacturer Narrative

DEVICE EVALUATION: AS THE DEVICE WAS NOT RETURNED TO KARL STORZ TUTTLTLINGEN A PHYSICAL EXAMINATION WAS NOT POSSIBLE. FURTHERMORE, NO LOT NUMBER WAS PROVIDED, THEREFORE A PRODUCT HISTORY REVIEW COULD NOT BE PERFORMED EITHER. THE LABELLING WAS FOUND TO CONTAIN ADEQUATE INSTRUCTIONS AND WARNINGS. ACCORDING TO THE CUSTOMER'S DESCRIPTION, A PART OF THE JAW OF ITEM 11274FE BROKE OFF IN THE BODY BUT COULD BE RECOVERED AFTERWARDS. A POSSIBLE CAUSE FOR THIS IS THAT IT WAS EITHER NOT USED FOR ITS INTENDED PURPOSE OR BROKE DUE TO MECHANICAL OVERLOAD. THE ITEM WAS NOT SENT TO KST FOR EXAMINATION, SO NO PRECISE STATEMENT IS POSSIBLE. THE AGE OF THE ITEM IS ALSO UNKNOWN, WHICH HAS A SIGNIFICANT IMPACT ON AN ARTICLE. IF NEW OR ADDITIONAL RELEVANT INFORMATION WILL BE RECEIVED, WE WILL REOPEN THE INVESTIGATION ACCORDINGLY. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).