MAUDE Adverse Event Report: TECHNOMED DISPOSABLE BIPOLAR PROBE; DISPOSABLE NERVE MONITORING PROBE

Model Number	3601-00-TE
Medical Device Problem Code	Failure to Analyze Signal (1539)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
During parotidectomy surgery, surgeons detected a nerve themselves which was not picked up by the device (probe) used.Using another probe, the nerve was detected.Surgeons concluded the device may have malfunctioned.

• Brand Name: DISPOSABLE BIPOLAR PROBE
• Common Device Name: DISPOSABLE NERVE MONITORING PROBE
• Manufacturer (Section D): TECHNOMED; amerikalaan 71; maastricht-airport, 6199A E; NL 6199AE
• MDR Report Key: 9381013
• Report Number: 9710376-2019-00001
• Device Sequence Number: 3042872
• Product Code: GXZ
• UDI-Device Identifier: 08718375864876
• UDI-Public: 08718375864876
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K050325
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/13/2019

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 Expiration Date: 05/01/2020
• Device Model Number: 3601-00-TE
• Device Lot Number: 042179
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2019
• Initial Report FDA Received Date: 11/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other