MAUDE Adverse Event Report: MEDTRONIC XOMED INC. APS¿ (AUTOMATIC PERIODIC STIMULATION) ELECTRODE; ELECTRODE, NEEDLE

Model Number	8228052
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis found the yellow c-clip contact was pulled back into the clip body.The contact of the returned sample was 0.07" away from the inside diameter, which was out of specification.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A health care professional (hcp) reported via a manufacturer representative that the probe had no signal during the thyroidectomy procedure.The procedure was delayed for about five minutes and another probe was used to detect better signals.This was the first time the probe was used.There was no patient impact.

• Brand Name: APS¿ (AUTOMATIC PERIODIC STIMULATION) ELECTRODE
• Common Device Name: ELECTRODE, NEEDLE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 7827992
• Report Number: 1045254-2018-00400
• Device Sequence Number: 11214794
• Product Code: GXZ
• UDI-Device Identifier: 00643169309326
• UDI-Public: 00643169309326
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K083124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/29/2018

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: 05/11/2022
• Device Model Number: 8228052
• Device Catalogue Number: 8228052
• Device Lot Number: 0215570615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2018
• Initial Report FDA Received Date: 08/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1