MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-05-12 for AUTOSUTURE COMPANY 120 MM SURGINEEDLE 172015 manufactured by Autosuture Company.
[11961]
Surgical procedure, laparoscopic assisted vaginal hysterectomy. Perforation of mesenteric artery and hematoma formation of retro-peritoneal area, following "inital" placement of disposable verres needle and trocar. More invasive and corrective intervention required. Exploratory laparotomy, ligation of bleeding mesenteric artery and exploration of the retro-peritoneal space/arota and ureter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 16974 |
| MDR Report Key | 16974 |
| Date Received | 1994-05-12 |
| Date of Report | 1993-10-14 |
| Date of Event | 1993-10-13 |
| Date Facility Aware | 1993-10-13 |
| Report Date | 1993-10-14 |
| Date Reported to Mfgr | 1993-10-14 |
| Date Added to Maude | 1994-10-20 |
| 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 |
| 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 COMPANY |
| Generic Name | SURGINEEDLE 120 MM |
| Product Code | HDH |
| Date Received | 1994-05-12 |
| Model Number | 120 MM SURGINEEDLE |
| Catalog Number | 172015 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 16907 |
| Manufacturer | AUTOSUTURE COMPANY |
| Manufacturer Address | 150 GLOVER AVE NORWALK CT 06856 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 1994-05-12 |