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 2017-02-09 for ENDO GIA* TRI-STAPLE RR 45MM M/T RELOAD EGIATRS45AMT manufactured by Covidien, Formerly Us Surgical A Divison.
[67088021]
(b)(4). (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[67088022]
According to the reporter; during an esophagectomy, the device only fired halfway. The procedure was completed by manual suturing. The surgical time was extended by more than 30 min. Additional tissue resection was required due to the issue. The incision site was not extended. Nothing fell into the patient's cavity. The device was removed from the tissue by force and tissue damage was caused. Oozing bleeding occurred as a result of the issue. The patient weight is not available. The device was not reprocessed/re-sterilized prior to use.
Patient Sequence No: 1, Text Type: D, B5
[96648640]
Evaluation summary: post market vigilance (pmv) led an evaluation of one device. The event report alleges the product was used in a surgical procedure. Visual and functional evaluation of the reload noted a deformed anvil clamping mechanism and knife blade 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; therefore, a device history record will not be performed. The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident. Replication of the deformed anvil clamping mechanism may occur under the following conditions. Application over tissue that is beyond the recommended thickness range. Application with an obstacle incorporated in the jaws. In any of these circumstances, it will become increasingly difficult to actuate the firing handle and the instrument return knobs will be difficult to retract. In addition, staples may not form properly and tissue may not be fully transected. Replication of the damaged knife blade may occur when an obstacle has been incorporated in the jaws during application. No relationship between the device and the reported incident was confirmed. 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 | 1219930-2017-00164 |
| MDR Report Key | 6315994 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-02-09 |
| Date of Report | 2017-05-25 |
| Date of Event | 2017-01-11 |
| Date Mfgr Received | 2017-05-25 |
| Date Added to Maude | 2017-02-09 |
| 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 M/T RELOAD |
| Generic Name | MESH, SURGICAL, DEPLOYER |
| Product Code | ORQ |
| Date Received | 2017-02-09 |
| Returned To Mfg | 2017-02-09 |
| Model Number | EGIATRS45AMT |
| Catalog Number | EGIATRS45AMT |
| 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 | 2017-02-09 |