MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-03 for ELECTRODE EXTENSION E1502 manufactured by Covidien Lp.
[30547384]
Covidien reference#: (b)(4). Date of initial report: 11/3/2015. The incident 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
[30547525]
The customer reported that during use of the device, sparks were seen. A little crack was noted on the electrode extension. A new extension was used. There was no patient injury. Covidien's initial evaluation of the incident device found the insulation was scratched down to bare metal. The extension failed hipot testing.
Patient Sequence No: 1, Text Type: D, B5
[31401009]
(b)(4). Evaluation of the incident electrode extension confirmed the insulation was compromised resulting in the device failing hipot testing. There was mechanical damage along the entire shaft of the insulation in the form of nicks and scrapes, with concentrated damage in the areas that failed hipot testing. The instructions for use warn the user to inspect the extension frequently (before and after each use) for cracks, nicks, cuts, dents or depressions, which may decrease the insulation effectiveness and may result in burns to the surgeon or patient.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1717344-2015-00778 |
| MDR Report Key | 5197774 |
| Date Received | 2015-11-03 |
| Date of Report | 2015-10-12 |
| Date of Event | 2015-10-08 |
| Date Mfgr Received | 2015-11-10 |
| Date Added to Maude | 2015-11-03 |
| 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 | ELECTRODE EXTENSION |
| Generic Name | ES ACCESSORY |
| Product Code | BWA |
| Date Received | 2015-11-03 |
| Returned To Mfg | 2015-10-23 |
| Model Number | E1502 |
| Catalog Number | E1502 |
| 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 | 2015-11-03 |