| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | CLIP, IMPLANTABLE, REPROCESSED | STERILMED, INC. | NMJ | ETHER320 | ETHER320 | Y | R |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-12-17 | 0 |
Patient 1
THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AS OF THE DATE OF THIS REPORT. A SUPPLEMENTAL REPORT WILL BE SENT AFTER THE DEVICE EVALUATION IF THE DEVICE IS RECEIVED. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED AS A LOT NUMBER WAS NOT GIVEN.
Patient 1
IT WAS REPORTED THAT DURING A PROCEDURE, THE CLIPS WERE COMING OUT OF THE DEVICE BENT, IN A SCISSORED FORMATION. THE SURGEON WAS ABLE TO REMOVE MOST OF THE CLIPS THAT MALFORMED. THOSE THAT COULD BE REMOVED WITHOUT RISKING PATIENT INJURY WERE CUT SHORT. IT WAS REPORTED THAT NO PATIENT INJURY OCCURRED.
Patient 1
THE DEVICE WAS RETURNED TO MANUFACTURER WITH CONTAMINANTS IN THE JAW AREA CONSISTENT WITH FIELD USE. AS REPORTED BY THE ACCOUNT, THE DEVICE HAD BEEN ACTUATED AND FIRED AN UNKNOWN NUMBER OF TIMES. IT WAS RETURNED WITH 8 CLIPS. THE DEVICE WAS FIRED DURING THE INVESTIGATION AND APPEARED TO FIRE AT A NORMAL SPEED WITH THE NEXT CLIP LOADING PROPERLY INTO THE JAWS. HOWEVER, THE FIRED CLIPS DID NOT HAVE THE PROPER PINCH OR ALIGNMENT DUE TO THE JAWS BEING MISALIGNED. THE ACCOUNT COMPLAINT HAS BEEN CONFIRMED HOWEVER UNABLE TO DETERMINE IF THE DEVICE WAS SENT OUT IN THIS CONDITION. THE DEVICE HAD BEEN USED AND THE DAMAGE MAY HAVE BEEN DUE TO CLOSING OVER A HARD OBJECT OR PLACING STRESS ON THE JAWS CAUSING THEM TO BECOME DISTORTED. AS DEVICE WAS USED, NO CONCLUSION AS TO THE ROOT CAUSE FOR THIS FAILURE COULD BE DETERMINED. THE DEVICE HISTORY REPORT WAS REVIEWED AND NO DISCREPANCIES WERE FOUND.