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 Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No evaluation has been completed at the time of this report as the device has not been returned.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A healthcare professional (hcp) reported via a manufacturer representative (rep) that the probe was functioning properly at the beginning of a parotid surgery.However, the doctor noticed the probe could not detect nerves during the operation.The doctor check all the connections but couldn't fix the problem, but when they tried a new probe it functioned properly.It was the initial use of the probe and the surgery was delayed for less than 3 minutes.It was noted that there was no patient symptoms or complications associated with the event.
Additional Manufacturer Narrative
The product analysis indicates that one opened sample of part number 8225101 from lot number 0214912151 was received.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.There was no intermittent behavior while manipulating the tip, connector, and wire.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 300uv.There was no evidence of improper manufacturing and no malfunction found as it relates to the complaint.There was 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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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: 7680080
• Report Number: 1045254-2018-00290
• Device Sequence Number: 920787
• Product Code: ETN
• UDI-Device Identifier: 00681490176682
• UDI-Public: 00681490176682
• 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: company representative,distri
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2018

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: 02/12/2026
• Device Model Number: 8225101
• Device Catalogue Number: 8225101
• Device Lot Number: 0214912151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• Initial Date Received by Manufacturer: 06/20/2018
• Supplement Date Received by Manufacturer: 08/01/2018; 08/08/2018
• Initial Report FDA Received Date: 07/11/2018
• Supplement Report FDA Received Date: 08/21/2018; 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1