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

Model Number	3334800T
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was returned for evaluation.Pre-repair temperature testing was performed.The following are the pre-repair temperatures: rear ¿ 24.8°c, middle- 24.2°c and nose- 67.0°f.Device evaluation is not complete at this time, completion of evaluation is anticipated.
Event or Problem Description
It was reported that during a tympanoplasty surgery the handpiece overheated.The procedure was completed with another handpiece.There was no patient impact.
Additional Manufacturer Narrative
Device evaluation has been completed.Analysis found that the inside of the device was deteriorated.There was dirt and rust on the nose, ball, o-ring, motor and bearing.The device also had an abnormal noise.The motor cable assembly, nose, ball, o-ring and bearing were replaced.The device was repaired, tested to all manufacturing product specifications and returned to the customer.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: XPS® HANDPIECE - VISAO®
• Common Device Name: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 6360930
• Report Number: 1045254-2017-00068
• Device Sequence Number: 39060
• 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: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/06/2017

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
• Device Lot Number: 61579600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2017
• Initial Date Received by Manufacturer: 02/06/2017
• Supplement Date Received by Manufacturer: Not provided; 03/07/2017
• Initial Report FDA Received Date: 02/27/2017
• Supplement Report FDA Received Date: 04/17/2017; 09/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1