CUEVA CRANIAL NERVE ELECTRODE CNE1-1SKDINX

MAUDE Adverse Event Report

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.

Event Text Entries

[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


MAUDE Entry Details

Report Number2183456-2013-00001
MDR Report Key2918590
Report Source05
Date Received2013-01-10
Date of Report2013-01-10
Date of Event2012-12-12
Date Mfgr Received2012-12-14
Date Added to Maude2013-04-02
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactLISA THEAMA
Manufacturer Street1901 WILLIAM STREET
Manufacturer CityRACINE WI 53404
Manufacturer CountryUS
Manufacturer Postal53404
Manufacturer Phone2626341555
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCUEVA CRANIAL NERVE ELECTRODE
Generic NameCUEVA CRANIAL NERVE ELECTRODE
Product CodeGYC
Date Received2013-01-10
Returned To Mfg2012-12-27
Catalog NumberCNE1-1SKDINX
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerAD-TECH MEDICLA INSTRUMETN CORP
Manufacturer AddressRACINE WI 53404 US 53404


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2013-01-10

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