DEK BL MF 0 TC-43/HR 26 2N
Received Mar 17, 2020 · Event occurred Feb 2, 2020
Report 3004365956-2020-00070 · MDR key 9845194
Device
Product problems
- Break
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. A VISUAL NOR FUNCTIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. A DEVICE HISTORY REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER NOR PRODUCT CODE WAS PROVIDED. A CORRECTIVE ACTION CANNOT BE DETERMINED DUE TO THE LACK OF PRODUCT CODE AND BATCH NUMBER TO PERFORM A PROPER INVESTIGATION TO DETERMINE A ROOT CAUSE. CUSTOMER COMPLAINT CANNOT BE CONFIRMED DUE TO THE LACK OF PRODUCT SAMPLE AND BATCH NUMBER TO PERFORM A PROPER INVESTIGATION TO DETERMINE A ROOT CAUSE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.
Description of Event or Problem
IT WAS REPORTED THAT THE CAPIO HANDLE DELIVERED THE BULLET ONLY PARTIALLY THROUGH THE SS LIGAMENT. MEANING, AFTER THROWING THE SUTURE AND WITHDRAWING THE HANDLE FROM THE PATIENT THE SUTURE WAS NOT IN THE CAPTURE DEVICE OF THE HANDLE. ALSO, THE SURGEON COULD NOT REMOVE THE BULLET/SUTURE FROM THE LIGAMENT. IT WAS DECIDED TO LEAVE THE BULLET IN THE PATIENT. A NEW HANDLE AND SUTURE WERE USED ON SUBSEQUENT THROW.