MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-08 for ETHICON POUCH manufactured by Ethicon/ Covidien.
[94550094]
Endocatch pouch broken during a laparoscopic tissue retrieval.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073877 |
| MDR Report Key | 7104461 |
| Date Received | 2017-12-08 |
| Date of Report | 2017-12-07 |
| Date of Event | 2017-12-04 |
| Date Added to Maude | 2017-12-11 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | 0 |
| Brand Name | ETHICON |
| Generic Name | ENDOCATCH |
| Product Code | GCI |
| Date Received | 2017-12-08 |
| Model Number | ETHICON |
| Catalog Number | POUCH |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ETHICON/ COVIDIEN |
| Manufacturer Address | IL 60805 US 60805 |
| Brand Name | ETHICON |
| Generic Name | ENDOCATCH |
| Product Code | KDW |
| Date Received | 2017-12-08 |
| Model Number | ETHICON |
| Catalog Number | POUCH |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON/ COVIDIEN |
| Manufacturer Address | IL 60805 US 60805 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-08 |