MAUDE Adverse Event Report: STRYKER INSTRUMENTS-FREIBURG LARYNGEAL ELECTRODE SELECT, ID 6-7MM; SURGICAL NERVE STIMULATOR/LOCATOR

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	03/29/2019
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 surgical delay, no medical intervention, and no adverse consequences.
Additional Manufacturer Narrative
Correction: reportability awareness date the reportability awareness date on the initial reported event was incorrect; the initial report was filed within 30 days of becoming aware that the reported event would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
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.
Additional Manufacturer Narrative
Additional information: product return date.Follow-up report submitted to document device evaluation results.
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.

• Brand Name: LARYNGEAL ELECTRODE SELECT, ID 6-7MM
• Common Device Name: SURGICAL NERVE STIMULATOR/LOCATOR
• Manufacturer (Section D): STRYKER INSTRUMENTS-FREIBURG; boetzingerstr. 41; freiburg MI D-791 11
• MDR Report Key: 8655719
• Report Number: 0001811755-2019-01853
• Device Sequence Number: 16794445
• Product Code: ETN
• UDI-Device Identifier: 37613327292207
• UDI-Public: 37613327292207
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 06/14/2019

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 Number: 5140-530-855
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2019
• Initial Date Received by Manufacturer: 03/29/2019
• Supplement Date Received by Manufacturer: 05/10/2019; 06/13/2019
• Initial Report FDA Received Date: 05/30/2019
• Supplement Report FDA Received Date: 06/04/2019; 06/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1