MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-01-27 for ENDO GIA* TRI-STAPLE RR 60MM M/T RELOAD EGIATRS60AMT manufactured by Covidien, Formerly Us Surgical A Divison.
[65964512]
(b)(4). Device manufacture date: since the lot number was not provided, this information cannot be determined. Surgical intervention required.
Patient Sequence No: 1, Text Type: N, H10
[65964513]
According to the reporter, the patient presented with a leak 12 days post op after a sleeve gastrectomy procedure, which was diagnosed through an esophagogastroduodenoscopy. The inter-operative leak test was negative. They put a drain in and a feeding tube. The patient is at home and is doing well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219930-2017-00113 |
| MDR Report Key | 6283598 |
| Report Source | USER FACILITY |
| Date Received | 2017-01-27 |
| Date of Report | 2017-01-03 |
| Date of Event | 2016-12-27 |
| Date Mfgr Received | 2017-01-03 |
| Date Added to Maude | 2017-01-27 |
| 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 M/T RELOAD |
| Generic Name | MESH, SURGICAL, DEPLOYER |
| Product Code | ORQ |
| Date Received | 2017-01-27 |
| 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; 2. Required No Informationntervention | 2017-01-27 |