MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-02-13 for ETHICON ENDOPATH 5125 manufactured by Ethicon, Inc..
[21631352]
When surgeon inserted trocar into abdomen, he noticed gas leaking from it. When he checked inside the trocar, he noticed that the diaphragm of the sleeve was missing a piece of the plastic. He is not sure if defect was present from beginning or not. Surgeon searched extensively inside pelvis in event piece might have gotten into abdomen, but found nothing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 19714 |
| MDR Report Key | 19714 |
| Date Received | 1995-02-13 |
| Date of Report | 1994-07-25 |
| Date of Event | 1994-07-12 |
| Date Facility Aware | 1994-07-12 |
| Report Date | 1994-07-13 |
| Date Reported to Mfgr | 1994-07-25 |
| Date Added to Maude | 1995-02-14 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 ENDOPATH |
| Generic Name | 512MM TRI-STAR TROCAR W/RADIOLUSCENT SLEEVE |
| Product Code | FBQ |
| Date Received | 1995-02-13 |
| Catalog Number | 5125 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 19618 |
| Manufacturer | ETHICON, INC. |
| Manufacturer Address | CINCINNATI OH 452422839 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1995-02-13 |