MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-09-09 for US SURGICAL 176657 * manufactured by Us Surgical.
[385744]
In 2005 pt underwent laparoscopic cholecystectomy. Us surgical endoclips were used during the procedure. The pt returned to the hospital 8/2005 with a right upper quadrant hematoma and was taken back to the or two days later for exploratory laparotomy with ligation of bleeding arteriole. The surgeon felt this was possibly related to a probable ligaclip equipment failure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 634946 |
| MDR Report Key | 634946 |
| Date Received | 2005-09-09 |
| Date of Report | 2005-09-09 |
| Date of Event | 2005-08-31 |
| Date Facility Aware | 2005-08-31 |
| Report Date | 2005-09-09 |
| Date Reported to FDA | 2005-09-09 |
| Date Reported to Mfgr | 2005-09-09 |
| Date Added to Maude | 2005-09-19 |
| 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 | US SURGICAL |
| Generic Name | LAPAROSCOPIC CLIP APPLIER |
| Product Code | DSS |
| Date Received | 2005-09-09 |
| Model Number | 176657 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 624514 |
| Manufacturer | US SURGICAL |
| Manufacturer Address | 150 GLOVER AVE. NORWALK CT 06856 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2005-09-09 |