MAUDE Adverse Event Report: MEDTRONIC, XOMED INC. XPS HANDPIECE - VISAO; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) I

Model Number	3334800T
Medical Device Problem Codes	Degraded (1153); Overheating of Device (1437); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: analysis found the handpiece overheating and noisy.An internal inspection confirmed that parts such as middle housing, shaft, stainless steel balls, o-rings, nose, and bearings had deteriorated due to dirt and rust.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A health care professional (hcp) reported that the handpiece overheated during use.On follow up, it was reported that it took over one minute before overheating occurred.A back up device was used to finish the procedure with no delay.It was also reported that there is no impact on neither the patient nor the staff.

• Brand Name: XPS HANDPIECE - VISAO
• Common Device Name: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) I
• Manufacturer (Section D): MEDTRONIC, XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 12281926
• Report Number: 1045254-2021-00432
• Device Sequence Number: 19762623
• Product Code: ERL
• UDI-Device Identifier: 00885074107349
• UDI-Public: 00885074107349
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K041523
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/05/2021

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 Model Number: 3334800T
• Device Catalogue Number: 3334800T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2021
• Initial Report FDA Received Date: 08/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1