MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-28 for SILSPORT 12 TEM INDICATION SILSPT12TA manufactured by Covidien, Formerly Us Surgical A Divison.
[51738614]
This report is being submitted under alternative summary reporting exemption (b)(4). This summary report is part of the (b)(6). One complaint was received during this report period. The investigation is currently pending. The reported device is labeled for single use. The device was not reprocessed and reused. No remedial action was taken.
Patient Sequence No: 1, Text Type: N, H10
[51738615]
This report summarizes 1 malfunction events which are associated with the unintentional separation of the device and/or its components from something to which it is connected or attached. Patient information was not confirmed for this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219930-2016-00756 |
| MDR Report Key | 5830677 |
| Date Received | 2016-07-28 |
| Date Added to Maude | 2016-07-28 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MATTHEW AMARAL |
| Manufacturer Street | 60 MIDDLETOWN AVE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034926373 |
| 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 | 0 |
| Brand Name | SILSPORT 12 TEM INDICATION |
| Generic Name | ANOSCOPE AND ACCESSORIES |
| Product Code | FER |
| Date Received | 2016-07-28 |
| Model Number | SILSPT12TA |
| Catalog Number | SILSPT12TA |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| 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 | 2016-07-28 |