MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-02-11 for ETHICON EL 314 * manufactured by Johnson And Johnson.
[385197]
In 2005 pt underwent a laparoscopic cholestertectomy at 0700. Pt became hypotensive around 1100. Was taken back to the or for another lap chole but was converted to an open after blood was found (small amt) in the upper abdomen. The area of bleeding was in the area of the posterior cystic artery branch, the clip had fallen off. Pt received 3 units of blood. Pt returned to surgery again at 1855 for bleeding diathesis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 572688 |
| MDR Report Key | 572688 |
| Date Received | 2005-02-11 |
| Date of Report | 2005-02-10 |
| Date of Event | 2005-01-13 |
| Date Facility Aware | 2005-02-02 |
| Report Date | 2005-02-11 |
| Date Reported to Mfgr | 2005-02-02 |
| Date Added to Maude | 2005-02-15 |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ETHICON |
| Generic Name | ENDO CLIP APPLIER |
| Product Code | DSS |
| Date Received | 2005-02-11 |
| Model Number | EL 314 |
| Catalog Number | * |
| Lot Number | R-9608P |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 562556 |
| Manufacturer | JOHNSON AND JOHNSON |
| Manufacturer Address | 4545 CREEK RD CINCINNATI OH 45242 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2005-02-11 |