MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-01-11 for ENDO GIA* TRI-STAPLE RR 60MM M/T RELOAD EGIATRS60AMT manufactured by Covidien, Formerly Us Surgical A Divison.
[64440056]
(b)(4). (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[64440057]
According to the reporter, the surgeon feels that the stiffness of staple lines created with reinforcement material is causing an increase in reflux in some of his patients.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219930-2017-00040 |
| MDR Report Key | 6240495 |
| Report Source | USER FACILITY |
| Date Received | 2017-01-11 |
| Date of Report | 2016-12-14 |
| Date Mfgr Received | 2016-12-14 |
| Date Added to Maude | 2017-01-11 |
| 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 |
| 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 M/T RELOAD |
| Generic Name | MESH, SURGICAL, DEPLOYER |
| Product Code | ORQ |
| Date Received | 2017-01-11 |
| Model Number | EGIATRS60AMT |
| Catalog Number | EGIATRS60AMT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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. Other | 2017-01-11 |