MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-09 for FT BIPOLAR RESECTION CORD WOLF FT0022W manufactured by Covidien Lp.
[45128839]
(b)(4). The device has been received and is under evaluation. When the device evaluation is complete a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[45128840]
The customer reported that 2 grey lead connectors detached from the cord when being unplugged from unit during the procedure. No patient injury. Initial evaluation of the cord found the device failed hipot testing.
Patient Sequence No: 1, Text Type: D, B5
[48415785]
Covidien reference #: (b)(4). Date of initial report: 05/09/2016. Date of follow-up report: 06/27/2016. Visual investigation confirmed the storz connector was melted. Hipot testing did not pass; further electrical testing could not be completed due to the damage. A dhr review was performed by the supplier. This review indicates that the product was manufactured to specifications and all required testing was successfully completed prior to the shipment of this lot. The root cause of the damage could not be confirmed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1717344-2016-00398 |
| MDR Report Key | 5642488 |
| Date Received | 2016-05-09 |
| Date of Report | 2016-04-13 |
| Date Mfgr Received | 2016-05-31 |
| Date Added to Maude | 2016-05-09 |
| 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 | 5920 LONGBOW DRIVE |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 2034925267 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FT BIPOLAR RESECTION CORD WOLF |
| Generic Name | WOLF CORD |
| Product Code | JOS |
| Date Received | 2016-05-09 |
| Returned To Mfg | 2016-04-12 |
| Catalog Number | FT0022W |
| 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 LP |
| Manufacturer Address | 5920 LONGBOW DRIVE BOULDER CO 80301 US 80301 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-09 |