MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-12-21 for ENDO GIA* TRI-STAPLE RR 45MM M/T RELOAD EGIATRS45AMT manufactured by Covidien, Formerly Us Surgical A Divison.
[63001279]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[63001280]
According to the reporter: occurred during a laparoscopic assisted distal gastrectomy procedure. The nurse loaded the powered handle with the reload. Checked the handle indicator, the adapter indicator, and the cartridge indicator, and all illuminated. The surgeon clamped the tissue and pushed the green button, but the status indicator blacked out. The device did not work. Re-connected the cartridge onto the adapter and the same result. Replaced by a new idrive handle, the firing was completed with no problem. The status of the patient is no problem.
Patient Sequence No: 1, Text Type: D, B5
[68256239]
Tracking number: (b)(4). Post market vigilance (pmv) led an evaluation of one reload. Visual analysis revealed no abnormalities. During functional evaluation, the device fired satisfactorily. Product analysis suggests the product was not used in a surgical procedure. A review of the device history record indicates this device lot number was released meeting all medtronic quality release specifications at the time of manufacture. The product analysis concluded there were no device abnormalities that would have caused or contributed to the reported incident. Therefore, our investigation was unable to establish a relationship between the device and the reported incident. Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219930-2016-01394 |
| MDR Report Key | 6194993 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-12-21 |
| Date of Report | 2016-12-05 |
| Date of Event | 2016-11-30 |
| Date Mfgr Received | 2017-01-20 |
| Device Manufacturer Date | 2016-06-01 |
| Date Added to Maude | 2016-12-21 |
| 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 | 2016-12-21 |
| Returned To Mfg | 2017-01-20 |
| Model Number | EGIATRS45AMT |
| Catalog Number | EGIATRS45AMT |
| Lot Number | N6F0807KX |
| Device Expiration Date | 2019-06-30 |
| 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 | 2016-12-21 |