MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-08-31 for AUTOSUTURE GIA-50 PREMIUM 030424 manufactured by Us Surgical Corp.
[11631]
It was reported that the stapler device failed to fire staples into the bowel. No patient injury is known. The device and packaging was not saved. No other information is available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 18988 |
| MDR Report Key | 18988 |
| Date Received | 1994-08-31 |
| Date of Report | 1994-06-29 |
| Date of Event | 1994-02-04 |
| Date Added to Maude | 1995-01-18 |
| 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 |
| Generic Name | DISPOSABLE STAPLER |
| Product Code | FHM |
| Date Received | 1994-08-31 |
| Model Number | GIA-50 PREMIUM |
| Catalog Number | 030424 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 18915 |
| Manufacturer | US SURGICAL CORP |
| Manufacturer Address | 150 GLOVER AVE NORWALK CT 06856 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-08-31 |