MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-04-19 for TAKAHASHI NASAL FORCEPS * N2995 manufactured by Storz Instruments.
[17100151]
Patient was undergoing a functional endoscopic sinus surgery and septoplasty. Physician was using takahashi forceps. He had the forceps in the nose, preparing to remove some tissue, when the top of the blade broke off in the nose. Pieces were removed and there was no harm to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2550902 |
| MDR Report Key | 2550902 |
| Date Received | 2012-04-19 |
| Date of Report | 2012-04-19 |
| Date of Event | 2012-04-12 |
| Report Date | 2012-04-19 |
| Date Reported to FDA | 2012-04-19 |
| Date Added to Maude | 2012-04-26 |
| 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 |
| 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 | TAKAHASHI NASAL FORCEPS |
| Generic Name | FORCEPS, NASAL |
| Product Code | JXX |
| Date Received | 2012-04-19 |
| Model Number | * |
| Catalog Number | N2995 |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 8 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STORZ INSTRUMENTS |
| Manufacturer Address | 2151 E. GRAND AVENUE EL SEGUNDO CA 90245 US 90245 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-04-19 |