MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-12-20 for ENDO GIA* TRI-STAPLE RR 60MM M/T RELOAD EGIATRS60AMT manufactured by Covidien, Formerly Us Surgical A Divison.
[62858369]
(b)(4). Additional attempts to obtain information and the device have been made. A supplemental report will be submitted with new details if they become available.
Patient Sequence No: 1, Text Type: N, H10
[62858370]
According to the reporter, during a gastric bypass, when using the reload to create the pouch, the knife blade stopped 3 times. Had to stop firing and let off the blue button for 30 seconds before continuing the firing. While firing, metal shavings were coming off of the staple load and into the patient. These shavings were removed. The reload was able to fire the full linear length, be removed from the tissue ok, and no problems were observed with the staple line. The procedure time was extended by about 10 minutes to remove the metal pieces.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219930-2016-01382 |
| MDR Report Key | 6190224 |
| Report Source | USER FACILITY |
| Date Received | 2016-12-20 |
| Date of Report | 2016-11-30 |
| Date of Event | 2016-11-30 |
| Date Mfgr Received | 2016-11-30 |
| Date Added to Maude | 2016-12-20 |
| 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 60MM M/T RELOAD |
| Generic Name | MESH, SURGICAL, DEPLOYER |
| Product Code | ORQ |
| Date Received | 2016-12-20 |
| Model Number | EGIATRS60AMT |
| Catalog Number | EGIATRS60AMT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2016-12-20 |