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 2016-09-23 for ENDO GIA* TRI-STAPLE RR 45MM ET RELOAD EGIATRS45AXT manufactured by Covidien, Formerly Us Surgical A Divison.
[55484695]
Tracking no: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[55484696]
According to the reporter: during a lobectomy procedure, after the first fire was successful, the user grasped lung tissue with the second reload, and some staples had come out of the root of the jaw. The pleura was torn a little as a result. The device had not been fired by the user. Another device was used to the complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
[58854031]
(b)(4)
Patient Sequence No: 1, Text Type: N, H10
[58854032]
Additional information received: the product will be returned for evaluation. The handle used with the reload was egia ultra universal short stapler, lost number not available. The torn tissue was sutured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219930-2016-01007 |
| MDR Report Key | 5973792 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-09-23 |
| Date of Report | 2016-08-29 |
| Date of Event | 2016-08-26 |
| Date Mfgr Received | 2016-10-20 |
| Device Manufacturer Date | 2016-02-01 |
| Date Added to Maude | 2016-09-23 |
| 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 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 | 2016-09-23 |
| Model Number | EGIATRS45AXT |
| Catalog Number | EGIATRS45AXT |
| Lot Number | N6B0447KX |
| Device Expiration Date | 2019-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2016-09-23 |