MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-17 for ENDOSCOPIC CAUTERY CORD 82306 823.06 manufactured by Richard Wolf Medical Instruments Corp..
[133333051]
Asked to increase the cautery from 30 to 40. It still did not work, then asked to increase to 60. There was a quick spark and the cord broke in half. Manufacturer response for endoscopic cautery cord, (brand not provided) (per site reporter). Manufacturer is working with our biomed staff and leadership.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8256356 |
| MDR Report Key | 8256356 |
| Date Received | 2019-01-17 |
| Date of Report | 2018-12-24 |
| Date of Event | 2018-10-15 |
| Report Date | 2018-12-24 |
| Date Reported to FDA | 2018-12-24 |
| Date Reported to Mfgr | 2019-01-17 |
| Date Added to Maude | 2019-01-17 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOSCOPIC CAUTERY CORD |
| Generic Name | ELECTRODE, ELECTROSURGICAL |
| Product Code | JOS |
| Date Received | 2019-01-17 |
| Model Number | 82306 |
| Catalog Number | 823.06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
| Manufacturer Address | 353 CORPORATE WOODS PKWY. VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-17 |