MAUDE Adverse Event Report: STRYKER INSTRUMENTS-FREIBURG C2 NERVEMONITOR, 4 CHANNEL; SURGICAL NERVE STIMULATOR/LOCATOR.

Catalog Number	5140-508-240
Medical Device Problem Codes	No Device Output (1435); Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was evaluated during the procedure when the event occurred, and the issue of the stimulation knob being turned off was resolved by turning the stimulation knob back on.The device was not returned to the manufacturer for evaluation.
Event or Problem Description
It was reported that during use in a procedure, the monitor was not providing auditory indication, because a user had accidently bumped a control knob and turned off the stimulation energy.This condition, in which the device does not delivery energy, may be interpreted by the user as a false negative result, posing increased risk of nerve injury.The procedure was completed successfully.There was no surgical delay, no medical intervention, and no adverse consequences.

• Brand Name: C2 NERVEMONITOR, 4 CHANNEL
• Common Device Name: SURGICAL NERVE STIMULATOR/LOCATOR.
• Manufacturer (Section D): STRYKER INSTRUMENTS-FREIBURG; boetzingerstr. 41; freiburg D-791 11
• MDR Report Key: 8934534
• Report Number: 0001811755-2019-02802
• Device Sequence Number: 525741
• Product Code: ETN
• UDI-Device Identifier: 07613327177329
• UDI-Public: 07613327177329
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K152505
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 08/27/2019

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: 5140-508-240
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2017
• Initial Report FDA Received Date: 08/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1811755-07/14/2019-001-R
• Patient Sequence Number: 1