MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-15 for SYMMETRY HANDLE 2000 manufactured by Symmetry Surgical Inc..
[37743227]
User facility indicated a blade came out of blade tip during a case, no patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007208013-2016-00003 |
| MDR Report Key | 5382840 |
| Date Received | 2016-01-15 |
| Date of Report | 2016-01-14 |
| Date of Event | 2015-12-15 |
| Date Facility Aware | 2015-12-16 |
| Date Mfgr Received | 2015-12-16 |
| Device Manufacturer Date | 2014-07-01 |
| Date Added to Maude | 2016-01-21 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. VICTORIA ROGERS |
| Manufacturer Street | 3034 OWEN DR |
| Manufacturer City | ANTIOCH TN 37013 |
| Manufacturer Country | US |
| Manufacturer Postal | 37013 |
| Manufacturer Phone | 8002513000 |
| Manufacturer G1 | SYMMETRY SURGICAL INC. |
| Manufacturer Street | 3034 OWEN DR |
| Manufacturer City | ANTIOCH TN 37013 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37013 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SYMMETRY HANDLE |
| Generic Name | HANDLE #2 FLAT 17CM L |
| Product Code | GDZ |
| Date Received | 2016-01-15 |
| Returned To Mfg | 2015-12-16 |
| Model Number | 2000 |
| Catalog Number | 2000 |
| Lot Number | 3084580 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYMMETRY SURGICAL INC. |
| Manufacturer Address | 3034 OWEN DR ANTIOCH TN 37013 US 37013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-15 |