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

Catalog Number	5140-508-240
Medical Device Problem Codes	Failure to Sense (1559); Device Displays Incorrect Message (2591); Noise, Audible (3273)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not returned for evaluation.
Event or Problem Description
It was reported that while electrocautery was in use during a procedure, the monitor was excessively beeping, displayed a dialog box on the screen when the stimulation probe was not in use, and had an intermittent loss of recording channel, which would return when electrocautery ended.These conditions, in which the device is delivering additional audible indication or has an inaccurate visible display, may be misunderstood by the user, 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: 8934548
• Report Number: 0001811755-2019-02812
• Device Sequence Number: 13607463
• 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: 03/26/2018
• 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