MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-11 for ENDO GIA* TRI-STAPLE RR 45MM M/T RELOAD EGIATRS45AMT manufactured by Covidien, Formerly Us Surgical A Divison.
[70058921]
(b)(4). Evaluation summary: post market vigilance (pmv) led an evaluation of one device opened by the account. This evaluation was based on a technical review of all data received from the site, a pmv review of complaint trends and an evaluation of the returned device. Visual examination of the reload noted that it was partially fired. The anvil clamping mechanism was deformed. Microscopic evaluation noted that the reload had damage to the cutting edge of the knife blade. During functional testing, the reload was loaded into a post market vigilance instrument. The interlock was overridden and the reload was then applied to test media. All remaining staples were placed and test media was roughly transected. Functional testing confirmed the safety interlock feature successfully prevented the reload from cycling again. Replication of the reported condition may occur of the idrive ultra powered handle stops firing before the lower clamp reaches the distal end, which is likely due to the firing force reaching the upper design limit of the endo gia reload. This may occur under the following conditions. Application over tissue that is beyond the recommended thickness range; application with an obstacle incorporated in the jaws. Replication of the anvil clamping mechanism deformation condition may occur under the following conditions: application over tissue that is beyond the recommended thickness range; application with an obstacle incorporated in the jaws. In either of these circumstances, it will become increasingly difficult to actuate the firing handle and the instrument return knobs will be difficult to retract. In addition, staples may not form properly and tissue may not be fully transected. Replication of the damaged knife blade may occur when an obstacle has been incorporated in the jaws during application. Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[70058922]
According to the reporter, the reload in the handle fired partially, so the jaw was opened and staples were taken back.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219930-2017-00226 |
| MDR Report Key | 6398154 |
| Date Received | 2017-03-11 |
| Date of Report | 2016-09-19 |
| Date of Event | 2016-09-19 |
| Date Mfgr Received | 2016-09-19 |
| Device Manufacturer Date | 2015-06-01 |
| Date Added to Maude | 2017-03-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SHARON MURPHY |
| Manufacturer Street | 60 MIDDLETOWN AVE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034925267 |
| Manufacturer G1 | COVIDIEN, FORMERLY US SURGICAL A DIVISON |
| Manufacturer Street | 60 MIDDLETOWN AVE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06473 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ENDO GIA* TRI-STAPLE RR 45MM M/T RELOAD |
| Generic Name | MESH, SURGICAL, DEPLOYER |
| Product Code | ORQ |
| Date Received | 2017-03-11 |
| Returned To Mfg | 2016-10-24 |
| Model Number | EGIATRS45AMT |
| Catalog Number | EGIATRS45AMT |
| Lot Number | N5F1017KX |
| Device Expiration Date | 2017-06-30 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN, FORMERLY US SURGICAL A DIVISON |
| Manufacturer Address | 60 MIDDLETOWN AVE NORTH HAVEN CT 06473 US 06473 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-11 |