MAUDE Adverse Event Report: STRYKER INSTRUMENTS-FREIBURG LARYNGEAL ELECTRODE SELECT, ID 7-9MM; SURGICAL NERVE STIMULATOR/LOCATOR

Catalog Number	5140-530-856
Medical Device Problem Codes	Failure to Sense (1559); Device Sensing Problem (2917); Impedance Problem (2950)
Health Effect - Clinical Code	Nerve Damage (1979)
Date of Event	02/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Failure analysis is in progress; additional information will be submitted once the quality investigation is completed.
Event or Problem Description
It was reported that during a total thyroidectomy procedure the ground needle impedance was intermittent, and nerve monitoring function was lost.It was reported a vocal cord nerve was transected, and the left thyroidectomy was not completed.
Additional Manufacturer Narrative
Product long description, product code, common device name, catalog #, concomitant medical products grid, pma/510(k)#, (b)(4).Follow-up report submitted to document device evaluation results.The reported malfunction, loss of recording channel, could be confirmed based on the evaluation of the laryngeal electrode, which was previously reported as the concomitant device.
Event or Problem Description
It was reported that during a total thyroidectomy procedure the ground needle impedance was intermittent, and nerve monitoring function was lost.It was reported a vocal cord nerve was transected, and the left thyroidectomy was not completed.

• Brand Name: LARYNGEAL ELECTRODE SELECT, ID 7-9MM
• Common Device Name: SURGICAL NERVE STIMULATOR/LOCATOR
• Manufacturer (Section D): STRYKER INSTRUMENTS-FREIBURG; boetzingerstr. 41; freiburg D-791 11
• MDR Report Key: 8455038
• Report Number: 0001811755-2019-00949
• Device Sequence Number: 1668790
• Product Code: ETN
• UDI-Device Identifier: 37613327292108
• UDI-Public: 37613327292108
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 5140-530-856
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2019
• Initial Date Received by Manufacturer: 02/27/2019
• Supplement Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 03/27/2019
• Supplement Report FDA Received Date: 07/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5140-530-856, LARYNGEAL ELECT, 7-9MM, SN# (B)(4)