MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-01-05 for ENDO GIA* TRI-STAPLE RR 60MM ET RELOAD EGIATRS60AXT manufactured by Covidien, Formerly Us Surgical A Divison.
[64014583]
(b)(4). (b)(6). User facility is listed in initial reporter. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[64014584]
According to the reporter, the reload was loaded properly on the powered handle and fired correctly until the i-beam got towards the end of the reload and it stopped. The surgeon retracted the i-beam, cut the reinforcement, and removed the stapler. Upon closer look the anvil of the stapler was bent. To correct the condition the user resected and re-stapled.
Patient Sequence No: 1, Text Type: D, B5
[66584635]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[76279386]
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[76279387]
According to the reporter: per additional information received, surgeon said no excessive use of the product was performed. There was no unanticipated tissue loss. The incision was not extended by more than one inch. There was no unanticipated blood loss of 500cc or more. Surgery time was not delayed by more than 30 minutes. No device fragment fell into the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219930-2017-00022 |
| MDR Report Key | 6227832 |
| Report Source | USER FACILITY |
| Date Received | 2017-01-05 |
| Date of Report | 2017-05-09 |
| Date of Event | 2016-12-08 |
| Date Mfgr Received | 2017-05-09 |
| Device Manufacturer Date | 2016-10-01 |
| Date Added to Maude | 2017-01-05 |
| 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 ET RELOAD |
| Generic Name | MESH, SURGICAL, DEPLOYER |
| Product Code | ORQ |
| Date Received | 2017-01-05 |
| Returned To Mfg | 2017-01-10 |
| Model Number | EGIATRS60AXT |
| Catalog Number | EGIATRS60AXT |
| Lot Number | N6K0289KX |
| Device Expiration Date | 2019-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2017-01-05 |