MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-06-08 for HAND-TROL * 60-2800-501 manufactured by Conmed Corp.
[5839686]
Doctor was using cautery on patient and tip of cautery pencil broke and fell into patient surgical field then broken piece retrived. No patient harm. ======================manufacturer response for cautery hand piece (hand-trol), hand-trol (per site reporter). ======================sales rep to investigate.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4826422 |
| MDR Report Key | 4826422 |
| Date Received | 2015-06-08 |
| Date of Report | 2015-06-08 |
| Date of Event | 2015-06-02 |
| Report Date | 2015-06-08 |
| Date Reported to FDA | 2015-06-08 |
| Date Reported to Mfgr | 2015-06-09 |
| Date Added to Maude | 2015-06-09 |
| 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 | HAND-TROL |
| Generic Name | CAUTERY PENCIL |
| Product Code | DWG |
| Date Received | 2015-06-08 |
| Model Number | * |
| Catalog Number | 60-2800-501 |
| Lot Number | 140721-4 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED CORP |
| Manufacturer Address | 525 FRENCH ROAD UTICA NY 13502 US 13502 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-08 |