MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-12-20 for ENDO GIA* TRI-STAPLE RR 60MM ET RELOAD EGIATRS60AXT manufactured by Covidien, Formerly Us Surgical A Divison.
[62851298]
(b)(4). Additional attempts to obtain information and the device have been made. A supplemental report will be submitted with new details if they become available.
Patient Sequence No: 1, Text Type: N, H10
[62851299]
According to the reporter, during a laparoscopic sleeve gastrectomy, the first reload was fired completely with success. The second reload used would not fire. The surgeon was able to complete the staple line with another device. Current patient status is good.
Patient Sequence No: 1, Text Type: D, B5
[86859654]
Evaluation summary: post market vigilance (pmv) led an evaluation of one device. Visual inspection of the cartridge revealed that the reload was pre-fired and engaged in interlock. Microscopic evaluation noted that the reload had damage to the cutting edge of the knife blade. Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture. Analysis concluded there were no assembly component related failures. 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. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219930-2016-01380 |
| MDR Report Key | 6190081 |
| Report Source | USER FACILITY |
| Date Received | 2016-12-20 |
| Date of Report | 2017-05-24 |
| Date of Event | 2016-11-29 |
| Date Mfgr Received | 2017-05-24 |
| Date Added to Maude | 2016-12-20 |
| 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 | 3 |
| Brand Name | ENDO GIA* TRI-STAPLE RR 60MM ET RELOAD |
| Generic Name | MESH, SURGICAL, DEPLOYER |
| Product Code | ORQ |
| Date Received | 2016-12-20 |
| Returned To Mfg | 2017-05-04 |
| Model Number | EGIATRS60AXT |
| Catalog Number | EGIATRS60AXT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2016-12-20 |