MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2015-11-25 for SYMMETRY RHOTON 80-1688 manufactured by Symmetry Surgical Inc..
[33785187]
Intraoperative, the tip of the instrument broke off. The surgeon was able to find the piece but we would like to see if there is any reporting needing to be done for this issue. A safety report was completed at the hospital.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007208013-2015-00036 |
| MDR Report Key | 5276840 |
| Report Source | USER FACILITY |
| Date Received | 2015-11-25 |
| Date of Report | 2015-11-24 |
| Date of Event | 2015-11-03 |
| Date Facility Aware | 2015-11-03 |
| Date Mfgr Received | 2015-11-03 |
| Date Added to Maude | 2015-12-09 |
| 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 370130000 |
| Manufacturer Country | US |
| Manufacturer Postal | 370130000 |
| Manufacturer Phone | 8002513000 |
| Manufacturer G1 | SYMMETRY SURGICAL INC. |
| Manufacturer Street | 3034 OWEN DR |
| Manufacturer City | ANTIOCH TN 370130000 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 370130000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SYMMETRY RHOTON |
| Generic Name | RHOTOH HOOK |
| Product Code | GDG |
| Date Received | 2015-11-25 |
| Model Number | 80-1688 |
| Catalog Number | 80-1688 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | I |
| 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 | 2015-11-25 |