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	04/18/2024
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during the procedure, the drill was plugged in and the irrigation and cooling tubing were properly set up.After a minute of drilling, the top portion of the drill was overheating.The clinical team put the drill aside for it to cool down and tried again and experienced the same issue.The surgery could not be completed.The event has resulted in a procedure delay.There was no injury to the patient.It was further stated that overheating at the top of the drill occurred within the first minute.The heat then radiated to the motor portion.Tested the drill and can confirm that the top of the drill overheated in less than a minute.Procedure was completed with backup device.Device being run at 80,000 rpm.Device being run at forward motion.Irrigation was being used, 15-25cc/min.
Additional Manufacturer Narrative
Missed to update the imf - f05 in initial report, updated now.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.
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.

• 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: 19349028
• Report Number: 1045254-2024-00754
• Device Sequence Number: 15261888
• Product Code: ERL
• UDI-Device Identifier: 00643169882690
• UDI-Public: 00643169882690
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K011321
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/02/2024

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: 217911620
• 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: 04/23/2024
• Supplement Date Received by Manufacturer: Not provided; 09/02/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 05/27/2024; 09/02/2024
• Date Device Manufactured: 06/17/2019
• 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