| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | CLIP, IMPLANTABLE, REPROCESSED | STERILMED, INC. | NMJ | ETHMCL20 | ETHMCL20 | 1766592 | Y | R |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-01-13 | 0 |
Patient 1
IT WAS REPORTED THAT DURING AN EXCISION ABDOMINAL WALL MASS, THE CLIPS WOULD NOT COMPLETELY CLOSE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE DEVICE WAS FIRED "A COUPLE OF TIMES" LATER OUTSIDE OF THE PATIENT, AND THE CLIPS WERE TEAR DROP SHAPED. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO ADDITIONAL INFORMATION WAS RECEIVED. A SUPPLEMENTAL REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Patient 1
FINAL DEVICE INVESTIGATION FOUND THAT THE DEVICE WAS RETURNED WITH ONE REMAINING CLIP IN THE JAW. FOUR TEAR DROP SHAPED CLIPS WERE RETURNED WITH THE DEVICE. THE DEVICE WAS ORIGINALLY SENT OUT WITH 17 CLIPS. UPON DEVICE EVALUATION, IT WAS FOUND THAT THE REMAINING CLIP WOULD NOT FIRE AS THE LOCKING MECHANISM WAS ENGAGED. IT APPEARED THAT THE LOCKING MECHANISM LOCKED OUT PREMATURELY DUE TO POSSIBLE DAMAGE TO THE FIRING MECHANISM. THE PUSH FORK WAS NOT IN POSITION BUT WAS RETRACTED BACK IN THE SHAFT AND HAD NO CONTACT WITH THE CLIP, CAUSING THE LAST CLIP NOT TO FIRE. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE NOTED. AS EACH DEVICE IS INSPECTED AND TEST FIRED PRIOR TO RELEASE, NO CONCLUSION COULD BE MADE AS TO WHAT MAY HAVE CAUSED THE REPORTED EVENT.