MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-11-11 for ENDO GIA* TRI-STAPLE RR 45MM ET RELOAD EGIATRS45AXT manufactured by Covidien, Formerly Us Surgical A Divison.
[59715004]
(b)(6). (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
[59715165]
According to the reporter, the patient was in his thirties and had fragile lung caused by smoking. He left the hospital without problem. When he was treated as an outpatient later, a fever was present. Upon the outpatient treatment on (b)(6), he still had a fever. According to a x-ray result, there was a suspicion of bleeding. Also, he was found to have a dark venous pleural effusion by drain. He has been running a 39 degree celsius fever. The patient's condition was treated with drainage and medication. The patient is currently under observation. The original procedure was a thoraco/pneumothorax. The event occurred/was noticed after the surgery. The patient age is not available. The patient weight is not available. The device was not reprocessed/re-sterilized prior to use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219930-2016-01179 |
| MDR Report Key | 6097810 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-11-11 |
| Date of Report | 2016-10-18 |
| Date of Event | 2016-08-07 |
| Date Mfgr Received | 2016-10-18 |
| Date Added to Maude | 2016-11-11 |
| 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 | 3 |
| Brand Name | ENDO GIA* TRI-STAPLE RR 45MM ET RELOAD |
| Generic Name | MESH, SURGICAL, DEPLOYER |
| Product Code | ORQ |
| Date Received | 2016-11-11 |
| Model Number | EGIATRS45AXT |
| Catalog Number | EGIATRS45AXT |
| 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. Required No Informationntervention | 2016-11-11 |