MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-07 for ARTHROCARE COBLATOR II COBLATOR 2 manufactured by Smith & Nephew Inc.
[27626825]
Patient Sequence No: 1, Text Type: N, H10
[27626826]
Doctor noticed after the procedure was completed that the patient had a small burn on the back part of the tongue. [stage 1-2, no additional medical treatment. ] the hand piece was given to biomed straighten out, but staff informed me that the hand piece was bent/flexed in a position required for the procedure. Cobalor used for tonsilectomy and adenoidectomy and dr reported burn. Wand and packaging given to material manager and machine taken out of service.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5131045 |
| MDR Report Key | 5131045 |
| Date Received | 2015-10-07 |
| Date of Report | 2015-10-06 |
| Date of Event | 2015-07-30 |
| Report Date | 2015-10-06 |
| Date Reported to FDA | 2015-10-06 |
| Date Reported to Mfgr | 2015-10-06 |
| Date Added to Maude | 2015-10-07 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARTHROCARE COBLATOR II |
| Generic Name | GENERATOR, ELECTROSURGICAL |
| Product Code | MUL |
| Date Received | 2015-10-07 |
| Returned To Mfg | 2015-08-13 |
| Model Number | COBLATOR 2 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW INC |
| Manufacturer Address | 76 S. MERIDIAN AVE OKLAHOMA CITY OH 73107 US 73107 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-10-07 |