MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-07-08 for ENDOPATH ELECTRO SURGERY PROBE PLUS II EPS03 * manufactured by Ethicon, Inc..
[89561]
Right angle tip of probe became dislodged. Surgeon unable to find in wound.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 109529 |
| MDR Report Key | 109529 |
| Date Received | 1997-07-08 |
| Date of Report | 1997-06-24 |
| Date of Event | 1997-06-15 |
| Date Facility Aware | 1997-06-15 |
| Report Date | 1997-06-24 |
| Date Reported to Mfgr | 1997-06-24 |
| Date Added to Maude | 1997-08-01 |
| 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 | ENDOPATH ELECTRO SURGERY PROBE PLUS II |
| Generic Name | MONOPOLAR CAUTERY SUCTION & IRRIGATION SHAFT |
| Product Code | FEH |
| Date Received | 1997-07-08 |
| Model Number | EPS03 |
| Catalog Number | * |
| Lot Number | J45971 |
| ID Number | * |
| Device Expiration Date | 2001-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 107658 |
| Manufacturer | ETHICON, INC. |
| Manufacturer Address | 4545 CREEK ROAD CINCINNATI OH 452422839 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-07-08 |