MAUDE Adverse Event Report: MEDTRONIC XOMED INC. IPC® FOOTPEDAL - LEGEND EHS; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number	EF200
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product analysis indicates that the reported issue could not be reproduced.There were no deviations found.The foot control was tested and successfully passed.
Event or Problem Description
It was reported that during a case, the handpiece was sitting on the trolley and suddenly powered on.The staff confirmed that the foot control was not pressed.The handpiece finally stopped when unplugged.A replacement handpiece was plugged in, but would not start, even when the foot control was pressed.The foot control was replaced, which resolved the issue.There was no patient injury.

• Brand Name: IPC® FOOTPEDAL - LEGEND EHS
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 6290162
• Report Number: 1045254-2017-00043
• Device Sequence Number: 19086963
• Product Code: HBE
• UDI-Device Identifier: 00613994384072
• UDI-Public: 00613994384072
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K081475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/06/2017

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: EF200
• Device Catalogue Number: EF200
• Device Lot Number: 58650900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2017
• Initial Report FDA Received Date: 01/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1