MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-01-31 for ETHICON 10/12 TRISTAR ENDOPATH manufactured by Ethicon-endosurgery.
[17824416]
Safety sheild on ethicon 10/12 disposable laparoscopic cannula and trocar did not work. Liver was lacerated upon insertion through umbilical incision.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 24862 |
| MDR Report Key | 24862 |
| Date Received | 1995-01-31 |
| Date of Report | 1994-10-20 |
| Date of Event | 1994-10-14 |
| Date Facility Aware | 1994-10-14 |
| Report Date | 1994-10-20 |
| Date Added to Maude | 1995-08-23 |
| 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 | ETHICON 10/12 TRISTAR ENDOPATH |
| Generic Name | LAPAROSCOPIC CANNULA TROCAR 512MM |
| Product Code | FBM |
| Date Received | 1995-01-31 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | 512 MM |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 25279 |
| Manufacturer | ETHICON-ENDOSURGERY |
| Manufacturer Address | 4545 CREST ROAD CINCINNATI OH 45242 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1995-01-31 |