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

Model Number	3334800
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that intra-op, the visao drill handpiece was getting hot.There was no patient impact.
Additional Manufacturer Narrative
H6: previously applied code of d14 is no longer applicable.H3: customer was contacted for additional information and device return.But there was no other information that was available with customer and the handpiece was not returned to medtronic.Therefore, returned device analysis was not able to be performed.Because the product was not returned to medtronic, we remain inconclusive as to what could have been the root cause of the reported event.There was no indication that the event was related to a possible manufacturing issue.Therefore, no device history record (dhr) review was performed.However, by looking at the service history of the device, it was found that the device was being used for more than a year with no repair i.E., for around 1 year 3 months.Per instructions for use, overheating of device can be caused by wear out or failure of component.Product experience suggests that the behavior is typical for the given the circumstances, or the failure o ccurred over a period of time.The most likely cause of the event could be anticipated use characteristics.The investigation determined that this event had foreseen risk and is included in monitoring, and therefore no further investigation was required.Common sequences of events and contributing factors that can lead to this event are documented in the risk management file.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: glen belmer ; 6743 southpoint drive north; jacksonville, FL 32216 ; 6122713209
• MDR Report Key: 19116508
• Report Number: 1045254-2024-00557
• Device Sequence Number: 12548064
• Product Code: ERL
• UDI-Device Identifier: 00643169882690
• UDI-Public: 00643169882690
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K011321
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2024

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: 3334800
• Device Catalogue Number: 3334800
• Device Lot Number: 216933753
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2024
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown