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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-FREIBURG LARYNGEAL ELECTRODE SELECT, ID 6-7MM; SURGICAL NERVE STIMULATOR/LOCATOR
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STRYKER INSTRUMENTS-FREIBURG LARYNGEAL ELECTRODE SELECT, ID 6-7MM; SURGICAL NERVE STIMULATOR/LOCATOR Back to Search Results
Catalog Number 5140-530-855
Medical Device Problem Code Failure to Sense (1559)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 11/15/2018
Type of Reportable Event Malfunction
Event or Problem Description
It was reported the device had a loss of signal during a surgical procedure at the user facility.This condition, in which the electrical circuit is incomplete, may result in the loss of nerve monitoring recording function, posing increased risk of transection of a nerve.The procedure was completed successfully.There was no surgical delay, no medical intervention, and no adverse consequences.
 
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Brand Name
LARYNGEAL ELECTRODE SELECT, ID 6-7MM
Common Device Name
SURGICAL NERVE STIMULATOR/LOCATOR
Manufacturer (Section D)
STRYKER INSTRUMENTS-FREIBURG
boetzingerstr. 41
freiburg D-791 11
MDR Report Key8651693
Report Number0001811755-2019-01835
Device Sequence Number16676828
Product Code ETN
UDI-Device Identifier37613327292207
UDI-Public37613327292207
Combination Product (Y/N)N
Initial Reporter StateAL
Initial Reporter CountryUS
PMA/510(K) Number
K091874
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue Number5140-530-855
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/10/2019
Initial Report FDA Received Date05/29/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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