MAUDE Adverse Event Report: STRYKER INSTRUMENTS-FREIBURG LARYNGEAL ELECTRODE UNIV CABLE; SURGICAL NERVE STIMULATOR/LOCATOR

Model Number	5140-530-663
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/12/2019
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 clinically significant delay, no medical intervention, and no adverse consequences.
Additional Manufacturer Narrative
Follow-up report submitted to document device evaluation results.H3 other text : product not available.
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 clinically significant delay, no medical intervention, and no adverse consequences.

• Brand Name: LARYNGEAL ELECTRODE UNIV CABLE
• Common Device Name: SURGICAL NERVE STIMULATOR/LOCATOR
• Manufacturer (Section D): STRYKER INSTRUMENTS-FREIBURG; boetzingerstr. 41; freiburg D-791 11; DE D-79111
• MDR Report Key: 8601124
• Report Number: 0001811755-2019-01651
• Device Sequence Number: 14038385
• Product Code: ETN
• UDI-Device Identifier: 07613327298109
• UDI-Public: 07613327298109
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K091874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2020

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 Model Number: 5140-530-663
• Device Catalogue Number: 5140-530-663
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/12/2019
• Supplement Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 05/10/2019
• Supplement Report FDA Received Date: 02/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1