MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-03-29 for ENDOPATH ELECTROSURGERY PROBE PLUS II EPS04 manufactured by Ethicon Endosurgery.
[7266]
Surgeon had a disposable probe inside a trocar in a pt's abdomen, when the probe spontaneously turned on without control of the dr.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1001286 |
| MDR Report Key | 12363 |
| Date Received | 1994-03-29 |
| Date of Report | 1994-03-17 |
| Date of Event | 1994-03-16 |
| Date Added to Maude | 1994-03-30 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOPATH ELECTROSURGERY PROBE PLUS II |
| Generic Name | CAUTERY/IRRIGATION/SUCTION |
| Product Code | FEH |
| Date Received | 1994-03-29 |
| Model Number | EPS04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 12363 |
| Manufacturer | ETHICON ENDOSURGERY |
| Manufacturer Address | CINCINNATI OH 452422839 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-03-29 |