MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-01-10 for CUEVA CRANIAL NERVE ELECTRODE CNE1-1SKDINX manufactured by Ad-tech Medicla Instrumetn Corp.
[3372540]
A surgeon was using the cueva electrode. During the procedure, a clear disc of what looked like glue or epoxy fell off the back disc part of the electrode into the cerebellopontine angle. The surgeon noticed the clear disc and was able to remove it. Monitoring of nerve function was discontinued, but there were no medical problems for the pt resulting form the product failure.
Patient Sequence No: 1, Text Type: D, B5
[10453746]
On (b)(6) 2012 ad-tech shipped 3 cne1-1skdinx to (b)(6). Ad-tech had not previously ever shipped these electrodes to this customer before. The cne1-1skdinx cueva electrode consists of a circle disc that is marked with ink and a small amount of silicone adhesive is placed over the ink. A visual and electrical inspection of the returned electrode was performed by a member of quality assurance and production and it was determined that the silicone glue that is placed over the inked disc is no longer present. The electrode passed all electrical testing. From 2010 - 2012 ad-tech has sold 325 pieces of these electrodes. There have been 0 (zero) similar complaint reported to ad-tech in this time frame. This is the first complaint regarding this particular device malfunction in the history of the electrode. At this time ad-tech is unable to determine the root cause of the device malfunction. A corrective action (car 0268) was opened on (b)(6) 2012 to investigate further.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 2183456-2013-00001 |
MDR Report Key | 2918590 |
Report Source | 05 |
Date Received | 2013-01-10 |
Date of Report | 2013-01-10 |
Date of Event | 2012-12-12 |
Date Mfgr Received | 2012-12-14 |
Date Added to Maude | 2013-04-02 |
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 | 0 |
Event Location | 0 |
Manufacturer Contact | LISA THEAMA |
Manufacturer Street | 1901 WILLIAM STREET |
Manufacturer City | RACINE WI 53404 |
Manufacturer Country | US |
Manufacturer Postal | 53404 |
Manufacturer Phone | 2626341555 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | CUEVA CRANIAL NERVE ELECTRODE |
Generic Name | CUEVA CRANIAL NERVE ELECTRODE |
Product Code | GYC |
Date Received | 2013-01-10 |
Returned To Mfg | 2012-12-27 |
Catalog Number | CNE1-1SKDINX |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Age | DA |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | AD-TECH MEDICLA INSTRUMETN CORP |
Manufacturer Address | RACINE WI 53404 US 53404 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2013-01-10 |