MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-12-15 for PNEUMOPERITONEUM NEEDLE 13CM * 26120JL manufactured by Karl Storz.
[542222]
During the surgical procedure of a diagnostic laparoscopy, laser of endometriosis and appendectomy, a vascular injury occurred. The veress needle was inspected and appeared to be functioning normally. Three attempts were made to place the veress needle into the peritoneal cavity. However, after each attempt, the pt pressure was high indicating placement was not in the peritoneal cavity. The veress needle sheath did not retract completely over the blunt edge. During the bowel manipulation for the appendectomy, a retroperitoneal hematoma was noted. A defect in the peritoneum was noted at the level of the umbilicus below where the veress needle had been inserted. Vascular surgery was consulted and no further indication for further exploration. Ct scan was done postoperatively and serial hematocrits were done to monitor the hematoma. Pt was admitted to the hospital postoperatively for monitoring. Pt discharged on 12/06 in stable condition.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 797318 |
| MDR Report Key | 797318 |
| Date Received | 2006-12-15 |
| Date of Report | 2006-12-14 |
| Date of Event | 2006-12-06 |
| Date Facility Aware | 2006-12-08 |
| Report Date | 2006-12-14 |
| Date Reported to Mfgr | 2006-12-14 |
| Date Added to Maude | 2006-12-26 |
| 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 | 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 | PNEUMOPERITONEUM NEEDLE 13CM |
| Generic Name | VERESS NEEDLE |
| Product Code | FHP |
| Date Received | 2006-12-15 |
| Model Number | * |
| Catalog Number | 26120JL |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 784853 |
| Manufacturer | KARL STORZ |
| Manufacturer Address | * CULVER CITY CA 902300837 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2006-12-15 |