MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-01-17 for LAPAROSCOPIC TROCAR 10MM SURGIPORT 171025 manufactured by Autosuture Co..
[11008]
Pt undergoing laparoscopic tubal fulguration sustained injury to bowel upon placement of umbilical trocar. Perforation repaired laparoscopically and pt transferred to hosp in satisfactory condition for overnight observation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 20005 |
| MDR Report Key | 20005 |
| Date Received | 1995-01-17 |
| Date of Report | 1995-01-17 |
| Date of Event | 1995-01-17 |
| Date Facility Aware | 1995-01-17 |
| Report Date | 1995-01-17 |
| Date Added to Maude | 1995-02-28 |
| 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 | LAPAROSCOPIC TROCAR |
| Generic Name | LAPAROSCOPIC TROCAR |
| Product Code | GEJ |
| Date Received | 1995-01-17 |
| Model Number | 10MM SURGIPORT |
| Catalog Number | 171025 |
| Lot Number | P4K76 |
| Device Expiration Date | 1999-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 19900 |
| Manufacturer | AUTOSUTURE CO. |
| Manufacturer Address | NORWALK CT 06856 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1995-01-17 |