MAUDE Adverse Event Report: MEDTRONIC XOMED INC. NIM® PROBE; STIMULATOR, NERVE

Model Number	8225101
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visually, there was no damage or anomalies in the construction of the device that would have resulted in the reported event.The tip fit securely in the handle.The resistance of the assembly shall measure less than 0.3ohms while using a 4-wire ohm meter (a 2-wire meter was used in lieu of the 4 wire); the actual measurement was 0.2 ohm.The probe was plugged into a nim system (with a patient simulator) using 1.0 ma stimulating current and 100uv threshold; when stimulating, the system returned 1.02 ma and a waveform / event tone over 200uv.There was no evidence of improper manufacturing and no out of specification condition identified as it relates to the complaint.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A distributor reported that the probe could not detect nerves.There was no signal when the probe contacted nerves and no error code was shown on the monitor.The problem was noticed at the very beginning of a thyroidectomy.The doctor checked all the connections and reconnected the probe but the probe still could not detect nerves.The issue was resolved when a new probe was used.The surgery was delayed for about 5 minutes.There was no patient injury reported.

• Brand Name: NIM® PROBE
• Common Device Name: STIMULATOR, NERVE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 7567956
• Report Number: 1045254-2018-00231
• Device Sequence Number: 11144041
• Product Code: ETN
• UDI-Device Identifier: 20681490176686
• UDI-Public: 20681490176686
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K934426
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/04/2018

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 Expiration Date: 11/26/2025
• Device Model Number: 8225101
• Device Catalogue Number: 8225101
• Device Lot Number: 0214481040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 06/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1