MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2000-04-19 for EVE TONSIL SNARE N6377 manufactured by Bausch & Lomb Surgical.
[152682]
During surgery in 2000, the tonsil snare froze, the snare wire went into the muscle in the throat. The dr had to use a scissor and a blade to remove the tonsil and the snare. Then, had to cut the muscle to remove the wire. The pt outcome was fine and there were no further problems.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1932180-2000-00002 |
| MDR Report Key | 274433 |
| Report Source | 05 |
| Date Received | 2000-04-19 |
| Date of Report | 2000-03-22 |
| Date of Event | 2000-03-22 |
| Date Facility Aware | 2000-03-22 |
| Report Date | 2000-03-22 |
| Date Reported to Mfgr | 2000-03-22 |
| Date Mfgr Received | 2000-03-22 |
| Date Added to Maude | 2000-04-24 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ROBIN EMS |
| Manufacturer Street | 3365 TREE COURT IND. BLVD |
| Manufacturer City | ST LOUIS MO 63122 |
| Manufacturer Country | US |
| Manufacturer Postal | 63122 |
| Manufacturer Phone | 6362263276 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EVE TONSIL SNARE |
| Generic Name | TONSIL SNARE |
| Product Code | KBZ |
| Date Received | 2000-04-19 |
| Model Number | NA |
| Catalog Number | N6377 |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 265634 |
| Manufacturer | BAUSCH & LOMB SURGICAL |
| Manufacturer Address | 499 SOVEREIGN CT. MANCHESTER MO 63011 US |
| Baseline Brand Name | EVE TONSIL SNARE |
| Baseline Generic Name | TONSIL SNARE |
| Baseline Model No | NA |
| Baseline Catalog No | N6377 |
| Baseline ID | NA |
| Baseline Device Family | TONSIL SNARE |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-04-19 |