MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-07-01 for AUTOSUTURE SURGINEEDLE (VERESS NEEDLE) UNK manufactured by United States Surgical Corp.
[48361]
Pre-op dx-acute appendicitis, rule out perforation. On 4/9/96, attempted diagnostic laparoscopy. While doing so, intragenic accidental injection of co2 into the liver causing a venous emboli, creating cardiac flutter-ventricular tachycardia with hypotension, requiring a cardiac resusitation and also 200 joule cardiac defibrillation intraop. Also did open appendectomy, exploratory laparotomy, placement of a drain. Right femoral arterial exploration with repair of the two catheter-related perforation of the femoral artery. Placement of the right femoral arterial line with no complications initially. Pt also received blood. Has developed thrombus of right common femoral artery (noted in progress notes). Has been on heparin and may be having surgery in future.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 84678 |
| MDR Report Key | 84678 |
| Date Received | 1996-07-01 |
| Date of Report | 1996-04-19 |
| Date of Event | 1996-04-09 |
| Date Facility Aware | 1996-04-09 |
| Report Date | 1996-04-19 |
| Date Reported to Mfgr | 1996-04-19 |
| Date Added to Maude | 1997-04-21 |
| 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 | AUTOSUTURE SURGINEEDLE (VERESS NEEDLE) |
| Generic Name | DISPOSABLE PNEUMOPERITONEUM NEEDLE |
| Product Code | FHP |
| Date Received | 1996-07-01 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 83930 |
| Manufacturer | UNITED STATES SURGICAL CORP |
| Manufacturer Address | 195 MCDERMOTT RD NORTH HAVEN CT 06473 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 1996-07-01 |