MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-12-01 for GREENBERG 50-1511 manufactured by Symmetry Surgical Inc..
[18001009]
(b)(6), surgical materials dept. Tech reported: during procedure surgeon attempted to make a positional adjustment of retraction arm holding retractor blade to patient's brain. The armature's handle bar became stuck in eye of tightening bolt, when it suddenly came loose. Retractor blade slipped and made an unplanned cut on brain. There was no additional medical intervention required that i was aware of.
Patient Sequence No: 1, Text Type: D, B5
[18117183]
(b)(4) - actual device not evaluated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007208013-2014-00018 |
| MDR Report Key | 4364510 |
| Report Source | 06 |
| Date Received | 2014-12-01 |
| Date of Report | 2014-11-06 |
| Date of Event | 2014-10-28 |
| Date Mfgr Received | 2014-10-28 |
| Date Added to Maude | 2015-01-13 |
| 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 |
| Manufacturer Street | 3034 OWEN DR |
| Manufacturer City | ANTIOCH TN 370130000 |
| Manufacturer Country | US |
| Manufacturer Postal | 370130000 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GREENBERG |
| Generic Name | SHORT ARM RETRACTOR |
| Product Code | GZT |
| Date Received | 2014-12-01 |
| Model Number | 50-1511 |
| Catalog Number | 50-1511 |
| Lot Number | 3093 |
| ID Number | 00887482017296 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYMMETRY SURGICAL INC. |
| Manufacturer Address | ANTIOCH TN 37013000 US 37013 0000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-01 |