MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-11-25 for SYMMETRY 32-790 manufactured by Symmetry Surgical.
[4134141]
Assistant surgeon was using metz scissors during surgical procedure to remove nylon/ tissue aortic graft. Instrument broke while attempting to use. All the pieces were removed form the pt. No injury happened to the pt or the surgeons.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007208013-2013-00012 |
| MDR Report Key | 3622145 |
| Report Source | 07 |
| Date Received | 2013-11-25 |
| Date of Report | 2013-11-19 |
| Date of Event | 2013-08-30 |
| Date Mfgr Received | 2013-09-19 |
| Date Added to Maude | 2014-03-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHRIS SMITH, DIR |
| Manufacturer Street | 3034 OWEN DRIVE |
| Manufacturer City | ANTIOCH TN 37013 |
| Manufacturer Country | US |
| Manufacturer Postal | 37013 |
| Manufacturer Phone | 5089984575 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYMMETRY |
| Generic Name | METZENBAUM CURVED SCISSOR |
| Product Code | GZX |
| Date Received | 2013-11-25 |
| Returned To Mfg | 2013-09-30 |
| Model Number | 32-790 |
| Catalog Number | 32-790 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYMMETRY SURGICAL |
| Manufacturer Address | 3034 OWEN DR ANTIOCH TN 37013 US 37013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-11-25 |