MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-29 for GIA STAPLER WITH DST SERIES TECHNOLOGY GIA8038L GIA8038S manufactured by Covidien Llc..
[146670545]
During anastomosis portion of surgery, covidien gia 80mm stapler fired and cut normally but no staples came out. Surgeon explained issue to covidien reps (b)(4) in room stating no staples were located in the stapler reload. Reload was new and not previously used. Bowel was cut but not stapled. Another anastomosis was completed. Stapler and misfired reload were saved and given to director of surgery along with reload lot numbers. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086976 |
| MDR Report Key | 8654360 |
| Date Received | 2019-05-29 |
| Date of Report | 2019-05-24 |
| Date of Event | 2019-04-16 |
| Date Added to Maude | 2019-05-30 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GIA STAPLER WITH DST SERIES TECHNOLOGY |
| Generic Name | STAPLER, SURGICAL |
| Product Code | GAG |
| Date Received | 2019-05-29 |
| Model Number | GIA8038L |
| Catalog Number | GIA8038S |
| Lot Number | P9A1199Y |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LLC. |
| Manufacturer Address | MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-29 |