MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-11-27 for SSI ULTRA MICRO RING FORCEPS 55-9055 manufactured by Symmetry Surgical Inc..
[4130627]
The tip of the forceps broke during decontamination. When they noticed that the forceps were broken, the forceps were not used in a procedure. No pts were involved or harmed as a result of the breakage.
Patient Sequence No: 1, Text Type: D, B5
[11515691]
The product has not been returned form the hospital yet. We will investigation the failure when the instrument is returned to symmetry surgical.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007208013-2013-00015 |
| MDR Report Key | 3622100 |
| Report Source | 07 |
| Date Received | 2013-11-27 |
| Date of Report | 2013-11-27 |
| Date of Event | 2013-11-14 |
| Date Mfgr Received | 2013-11-14 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHRIS SMITH, DR |
| Manufacturer Street | 3034 OWEN DRIVE |
| Manufacturer City | ANTIOCH TN 37013 |
| Manufacturer Country | US |
| Manufacturer Postal | 37013 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SSI ULTRA MICRO RING FORCEPS |
| Generic Name | MICRO RING FORCEPS |
| Product Code | GZX |
| Date Received | 2013-11-27 |
| Model Number | 55-9055 |
| Catalog Number | 55-9055 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| 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 37013 US 37013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-11-27 |