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

Model Number	3334800T
Medical Device Problem Code	Vibration (1674)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: the following devices were used together with the handpiece during the procedure.Product id: p3334610, serial/lot#: unknown; product id: 3334625, serial/lot#: unknown; product id: 3334635, serial/lot#: unknown.Product analysis: - 3334800t : during the incoming inspection, wobbling could not be confirmed, but it was confirmed that abnormal noises were heard during operation of the handpiece.Upon conducting an internal inspection, deterioration of parts such as stainless steel balls, o-rings, noses, and bearings were confirmed due to dirt and rust.- 3334610 : upon receiving the device, it was confirmed that the o-ring had deteriorated.- 3334625 <(>&<)> 3334635 (extended burguard i): during the inspection, it was confirmed that the bearing and o-ring were deteriorating.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A healthcare professional (hcp) reported that the device is wobbling during use.On follow-up, it was mentioned that the device was vibrating while using on the patient, during a tympanoplasty procedure.There was no delay in the procedure and no backup device was used.There was no patient or staff impact.
Additional Manufacturer Narrative
Concomitant medical products: the following devices were used together with the handpiece during the procedure.Product id: p3334610, serial/lot#: unknown; product id: 3334625, serial/lot#: unknown; product id: 3334635, serial/lot#: unknown.Product analysis: - 3334800t: during the incoming inspection, wobbling could not be confirmed, but it was confirmed that abnormal noises were heard during operation of the handpiece.Upon conducting an internal inspection, deterioration of parts such as stainless steel balls, o-rings, noses, and bearings were confirmed due to dirt and rust.- 3334610: upon receiving the device, it was confirmed that the o-ring had deteriorated.- 3334625 & 3334635 (extended burguard i): during the inspection, it was confirmed that the bearing and o-ring were deteriorating.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A healthcare professional (hcp) reported that the device is wobbling during use.On follow-up, it was mentioned that the device was vibrating while using on the patient, during a tympanoplasty procedure.There was no delay in the procedure and no backup device was used.There was no patient or staff impact.

• 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: 12951497
• Report Number: 1045254-2021-00666
• Device Sequence Number: 4803620
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/07/2021

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 Expiration Date: 12/31/2015
• Device Model Number: 3334800T
• Device Catalogue Number: 3334800T
• Device Lot Number: 38227300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2021
• Initial Report FDA Received Date: 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2009
• 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