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

Catalog Number	5140-530-856
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/06/2019
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
Additional information: h4-manufacture 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 7-9MM
• Common Device Name: SURGICAL NERVE STIMULATOR/LOCATOR
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8754753
• Report Number: 0001811755-2019-02185
• Device Sequence Number: 19343735
• Product Code: ETN
• UDI-Device Identifier: 37613327292184
• UDI-Public: 37613327292184
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/20/2020

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 Catalogue Number: 5140-530-856
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2019
• Initial Date Received by Manufacturer: 06/06/2019
• Supplement Date Received by Manufacturer: 01/08/2020
• Initial Report FDA Received Date: 07/02/2019
• Supplement Report FDA Received Date: 01/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1