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

Model Number	1898430
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product evaluation: analysis results are not available; evaluation expected but not yet begun.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The facility reported that the foot pedal is activating handpieces when it is not being pressed on.The fault was confirmed with multiple units.A backup foot pedal was used for this procedure.There was no patient impact.
Additional Manufacturer Narrative
Product evaluation: the foot switch 1898430, s/n (b)(4), was received in service and repair; however, the report of "the foot pedal activating handpieces when it is not being pressed on" could not be confirmed.There was no deviation from specifications found; unable to reproduce reported fault.The device was successfully tested to specifications.If information is provided in the future, a supplemental report will be issued.

• Brand Name: IPC® FOOTPEDAL
• Common Device Name: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr north; jacksonville FL 32216
• MDR Report Key: 7028634
• Report Number: 1045254-2017-00408
• Device Sequence Number: 16524705
• Product Code: ERL
• UDI-Device Identifier: 00613994436405
• UDI-Public: 00613994436405
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K081277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2018

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: 1898430
• Device Catalogue Number: 1898430
• Device Lot Number: 207884783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2017
• Supplement Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 11/14/2017
• Supplement Report FDA Received Date: 03/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1