MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-12-06 for SYMMETRY SURGICAL FENESTRATED GRASPER TIP 5MM 0 3222 manufactured by Symmetry Surgical Inc..
[4201356]
Long fenestrated grasper was used during a laparoscopic hysterectomy when the tip broke. There was a delay in treatment as the pt was x-rayed while still under anesthesia.
Patient Sequence No: 1, Text Type: D, B5
[11635988]
Product was not returned to symmetry surgical for eval.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007208013-2013-00019 |
| MDR Report Key | 3653199 |
| Report Source | 07 |
| Date Received | 2013-12-06 |
| Date of Report | 2013-12-06 |
| Date of Event | 2013-12-06 |
| Date Mfgr Received | 2013-12-06 |
| Date Added to Maude | 2014-04-04 |
| 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, DIR |
| Manufacturer City | ANTIOCH TN 37013 |
| Manufacturer Country | US |
| Manufacturer Postal | 37013 |
| Manufacturer Phone | 8002513000 |
| Single Use | 0 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYMMETRY SURGICAL FENESTRATED GRASPER TIP 5MM |
| Generic Name | FENESTRATED GRASPER TIP |
| Product Code | GZX |
| Date Received | 2013-12-06 |
| Model Number | 0 3222 |
| Catalog Number | 0 3222 |
| Operator | LAY USER/PATIENT |
| 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 | 3034 OWEN DR ANTIOCH TN 37013 US 37013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-12-06 |