MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-04-13 for ASPEN SURGICAL PRODUCTS * manufactured by Aspen Surgical Products.
[17171411]
End of 7 gauge tonsil snare (x2) broke off during procedure (tonsillectomy). Surgeon irrigated and suctioned copiously and x-ray x3. Tonsils x-rayed also post-procedure. Snare was not found. Snare probably retained within instrument (snare gun). 8 gauge tonsil snare was used for procedure. Packaging of different size tonsil snares similar.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 326701 |
| MDR Report Key | 326701 |
| Date Received | 2001-04-13 |
| Date of Report | 2001-04-06 |
| Date of Event | 2001-03-19 |
| Date Facility Aware | 2001-03-19 |
| Report Date | 2001-04-06 |
| Date Reported to FDA | 2001-04-09 |
| Date Reported to Mfgr | 2001-04-09 |
| Date Added to Maude | 2001-04-17 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASPEN SURGICAL PRODUCTS |
| Generic Name | TONSIL SNARE |
| Product Code | KBZ |
| Date Received | 2001-04-13 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 316102 |
| Manufacturer | ASPEN SURGICAL PRODUCTS |
| Manufacturer Address | 7425 CLYDE PARK SUITE G GRAND RAPIDS MI 49509 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-04-13 |