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

Model Number	EF201
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product analysis indicates the foot control cable was cut.The cable/motor connector assembly was replaced.The foot control was repaired, cleaned, and passed to manufacturing specifications.
Event or Problem Description
It was reported that intraoperative, the foot control was at rest/inactive and activated the handpiece on its own.There was no patient injury.
Additional Manufacturer Narrative
Corrected information: sex.If information is provided in the future, a supplemental report will be issued.

• 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: 6622345
• Report Number: 1045254-2017-00177
• Device Sequence Number: 10918823
• Product Code: HBE
• UDI-Device Identifier: 00643169304475
• UDI-Public: 00643169304475
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K081475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2017

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: EF201
• Device Catalogue Number: EF201
• Device Lot Number: 210297579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2017
• Initial Date Received by Manufacturer: 05/15/2017
• Supplement Date Received by Manufacturer: 05/15/2017
• Initial Report FDA Received Date: 06/08/2017
• Supplement Report FDA Received Date: 10/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 107