MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-03-12 for ROUND KNIFE 39-500 manufactured by Ambler Surgical.
[5761248]
The pt was undergoing a right tympanomastoidectomy, while putting the round knife into the pt's ear, the knife broke in two pieces and the broken pieces of the round knife were recovered. There was no harm to the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5041491 |
| MDR Report Key | 4613491 |
| Date Received | 2015-03-12 |
| Date of Report | 2015-03-12 |
| Date of Event | 2015-02-10 |
| Date Added to Maude | 2015-03-19 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROUND KNIFE |
| Generic Name | ROUND KNIFE |
| Product Code | JYO |
| Date Received | 2015-03-12 |
| Model Number | 39-500 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMBLER SURGICAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-12 |