MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-11-08 for ENDO GIA* TRI-STAPLE RR 60MM ET RELOAD EGIATRS60AXT manufactured by Covidien, Formerly Us Surgical A Divison.
[59450618]
Manufacturer reference number: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[59450619]
According to the reporter: occurred during a laparoscopic sleeve gastrectomy procedure. The device did not function. The reload partially fired. Had to cut the stapler out of the stomach. Opened a new reload to finish the procedure.
Patient Sequence No: 1, Text Type: D, B5
[62859769]
Manufacturer reference number: (b)(4). No further details regarding patient, product or procedure were provided by the reporter. Should additional information become available, the file will be updated.
Patient Sequence No: 1, Text Type: N, H10
[68788968]
(b)(4). Evaluation summary: post market vigilance (pmv) led an evaluation of one (1) reload opened by the account. Visual inspection of the reload noted that there was a full complement of staples and the trs material that is secured under the distal anvil suture was pulled from underneath the intact suture. Functional evaluation noted that the reload fired as expected. The investigation results could not be confirmed. Replication of the buttress material position may occur if the reinforcement material is pulled toward the distal end of the reload. Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219930-2016-01168 |
| MDR Report Key | 6087465 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-11-08 |
| Date of Report | 2016-10-13 |
| Date of Event | 2016-06-26 |
| Date Mfgr Received | 2017-02-01 |
| Device Manufacturer Date | 2016-04-30 |
| Date Added to Maude | 2016-11-08 |
| 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 | 2016-11-08 |
| Returned To Mfg | 2016-11-30 |
| Model Number | EGIATRS60AXT |
| Catalog Number | EGIATRS60AXT |
| Lot Number | N6D0788KX |
| Device Expiration Date | 2019-04-30 |
| 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 | 1. Required No Informationntervention | 2016-11-08 |