MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-10 for ENSEAL TRIO ETRIO335H manufactured by Ethicon Endo-surgery, Inc..
[178749528]
Enseal device opened to fill and connected, but device was not cutting the tissue. Reset tool, unplugged and plugged back in but still did not work. Had to replace item. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092913 |
| MDR Report Key | 9694322 |
| Date Received | 2020-02-10 |
| Date of Report | 2020-02-06 |
| Date of Event | 2020-02-03 |
| Date Added to Maude | 2020-02-11 |
| 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 | 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 TRIO |
| Generic Name | LAPAROSCOPE, GENERAL PLASTIC SURGERY REPROCESSED |
| Product Code | NLM |
| Date Received | 2020-02-10 |
| Catalog Number | ETRIO335H |
| Lot Number | T94T2N |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON ENDO-SURGERY, INC. |
| Manufacturer Address | GUAYNABO PR 00969 US 00969 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-10 |