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 2017-02-17 for ENDO GIA* TRI-STAPLE RR 45MM M/T RELOAD EGIATRS45AMT manufactured by Covidien, Formerly Us Surgical A Divison.
[67703019]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[67703020]
According to the reporter, during a total gastrectomy / double tract after the y limb side-to-side anastomosis, the surgeon fired the device to close the insertion part; however 3 of the staple lines on one side were not stapled at all. The surgical time was extended by more than 30 minutes and additional tissue resection was required due to the issue. There was tissue damage. The procedure was completed with another device. The last known status of the patient is reported as no problem. No reinforcement material was used.
Patient Sequence No: 1, Text Type: D, B5
[78712420]
Evaluation summary: post market vigilance (pmv) led an evaluation of one device. Visual and functional evaluation noted there was damage to one side of the staple cartridge. Engineering could not determine the cause of the damage. Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture. Analysis concluded there were no assembly component related failures. The root cause of the damage could not be reliably determined. The damage seen could possibly be replicated be an obstruction between the jaws. Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate. 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
| Report Number | 1219930-2017-00183 |
| MDR Report Key | 6338841 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-02-17 |
| Date of Report | 2017-01-19 |
| Date of Event | 2017-05-22 |
| Date Mfgr Received | 2017-05-22 |
| Device Manufacturer Date | 2016-05-01 |
| Date Added to Maude | 2017-02-17 |
| 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 45MM M/T RELOAD |
| Generic Name | MESH, SURGICAL, DEPLOYER |
| Product Code | ORQ |
| Date Received | 2017-02-17 |
| Returned To Mfg | 2017-02-09 |
| Model Number | EGIATRS45AMT |
| Catalog Number | EGIATRS45AMT |
| Lot Number | N6E0112KX |
| Device Expiration Date | 2019-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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; 2. Deathisabilit | 2017-02-17 |