MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-08-15 for ACCUMESH * AMPPCO15X manufactured by Covidien.
[21810235]
The surgeon was using the device to position and deploy surgical mesh as part of a laparoscopic hernia repair. The device successfully deployed the mesh as intended by the surgeon, but the device would not retract/close. The surgeon noted a wire protruding from the device. The surgeon was able to use a grasper to re-position the wire and close the device so it could be retracted from the patient. The surgeon was able to complete the procedure as intended with no harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4053810 |
| MDR Report Key | 4053810 |
| Date Received | 2014-08-15 |
| Date of Report | 2014-08-15 |
| Date of Event | 2014-07-30 |
| Report Date | 2014-08-15 |
| Date Added to Maude | 2014-09-03 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCUMESH |
| Generic Name | SURGICAL MESH DEPLOYER |
| Product Code | ORQ |
| Date Received | 2014-08-15 |
| Model Number | * |
| Catalog Number | AMPPCO15X |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 60 MIDDLETOWN AVE. NORTH HAVEN CT 06473 US 06473 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-15 |