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	12/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The foot switch has been returned.Analysis results pending completion of evaluation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported the handpiece stalled, then operated at low rpm when the foot switch was not pressed.The console (ec300) was used with the foot switch when the event occurred.There was no patient impact.Report 1 of 2 - foot switch.
Additional Manufacturer Narrative
Summary of analysis: analysis result indicates that customer's complaint was not able to confirm but found the slip resistant pad was loose and not adhering.The slip resistant pad was replaced.The foot switch was tested and confirmed there was no fault found with the device.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 n; jacksonville FL 32216
• MDR Report Key: 7187552
• Report Number: 1045254-2018-00019
• Device Sequence Number: 1496839
• 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): 02/07/2018

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: 212264092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2017
• Supplement Date Received by Manufacturer: 01/26/2018
• Initial Report FDA Received Date: 01/12/2018
• Supplement Report FDA Received Date: 02/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1