MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-31 for ENSEAL NSLG2S45A manufactured by Ethicon Endo-surgery, Inc.
[185707123]
Enseal device began peeling while in use during laparoscopic procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9902818 |
| MDR Report Key | 9902818 |
| Date Received | 2020-03-31 |
| Date of Report | 2018-11-19 |
| Date of Event | 2018-10-11 |
| Report Date | 2020-03-18 |
| Date Reported to FDA | 2020-03-18 |
| Date Reported to Mfgr | 2020-03-31 |
| Date Added to Maude | 2020-03-31 |
| 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 | RISK MANAGER |
| 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 | ENSEAL |
| Generic Name | ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES |
| Product Code | GEI |
| Date Received | 2020-03-31 |
| Model Number | NSLG2S45A |
| Catalog Number | NSLG2S45A |
| Lot Number | R9319L |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON ENDO-SURGERY, INC |
| Manufacturer Address | 4545 CREEK ROAD CINCINNATI OH 45242 US 45242 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |