MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-10-23 for VHA PLUS (ETHICON) UV120-VERESS NEEDLE * manufactured by Ethicon Endo-surgery.
[19782740]
Pt for laparoscopic cholecystectomy. Upon insertion of veress needle, right iliac artery was punctured. Laparotomy was performed for repair of artery and cholecystectomy performed open.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 193090 |
| MDR Report Key | 193090 |
| Date Received | 1998-10-23 |
| Date of Report | 1998-09-24 |
| Date of Event | 1998-09-16 |
| Date Facility Aware | 1998-09-16 |
| Report Date | 1998-09-24 |
| Date Added to Maude | 1998-10-26 |
| 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 | VHA PLUS (ETHICON) |
| Generic Name | CHOLECYSTECTOMY TRAY |
| Product Code | FHP |
| Date Received | 1998-10-23 |
| Model Number | UV120-VERESS NEEDLE |
| Catalog Number | * |
| Lot Number | L4AN6U |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 187627 |
| Manufacturer | ETHICON ENDO-SURGERY |
| Manufacturer Address | 4545 CREEK RD. CINCINNATI OH 452422839 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1998-10-23 |