MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-29 for AUTO SUTURE GIA 90 PREMIUM A)K3G0012D B)030735 manufactured by Us Surgical Corporation.
[6825]
Patient for bowel surgery-staple gun being used for anastamosis near rectum. Air leak noted after use. Appeared to have fired only halfway. Invalid data - regarding single use labeling of device. Patient medical status prior to event: invalid data. Invalid data - regarding multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. Invalid data - regarding whether event presents imminent hazard. Invalid data - whether device used as labeled/intended. Device was not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9277 |
| MDR Report Key | 9277 |
| Date Received | 1994-07-29 |
| Date of Report | 1994-07-11 |
| Report Date | 1994-07-11 |
| Date Reported to Mfgr | 1994-03-23 |
| Date Added to Maude | 1994-12-07 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AUTO SUTURE GIA 90 PREMIUM |
| Generic Name | COLON STAPLE GUN/SUTURE CARTRIDGE |
| Product Code | FHM |
| Date Received | 1994-07-29 |
| Model Number | A)K3G0012D B)030735 |
| Device Availability | * |
| Implant Flag | * |
| Device Sequence No | 1 |
| Device Event Key | 8935 |
| Manufacturer | US SURGICAL CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-07-29 |