MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-26 for MALIS NERVE HOOK GERMANY 096 80-1532 manufactured by Symmetry Surgical, Inc..
[58381199]
Patient Sequence No: 1, Text Type: N, H10
[58381200]
Tip of nerve hook broke off during surgery. Tip of nerve hook was found in the drapes prior to the end of the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6056863 |
| MDR Report Key | 6056863 |
| Date Received | 2016-10-26 |
| Date of Report | 2016-09-20 |
| Date of Event | 2016-05-31 |
| Report Date | 2016-06-24 |
| Date Reported to FDA | 2016-06-24 |
| Date Reported to Mfgr | 2016-06-24 |
| Date Added to Maude | 2016-10-26 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MALIS NERVE HOOK |
| Generic Name | HOOK, SURGICAL, GENERAL & PLASTIC SURGERY |
| Product Code | GDG |
| Date Received | 2016-10-26 |
| Model Number | GERMANY 096 |
| Catalog Number | 80-1532 |
| ID Number | 81 CE |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYMMETRY SURGICAL, INC. |
| Manufacturer Address | 3034 OWEN DRIVE ANTIOCH TN 37013 US 37013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-26 |