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

Model Number	EF200
Medical Device Problem Code	Device Remains Activated (1525)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis found that the customer's complaint could not be duplicated but found that line master pcb zero gain potentiometer was partially disconnected from the pcb; this could have caused the malfunction of the pedal.Line master pcb to be replaced.Cordset cable had scratches.Safety tape was worn off.Replaced the parts.Tested the unit good as per specifications.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A health care provider reported that the foot control runs when not pressed, rpms also goes up and down.There was no patient impact.

• 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: 11805738
• Report Number: 1045254-2021-00235
• Device Sequence Number: 14367302
• Product Code: HBE
• UDI-Device Identifier: 00613994384072
• UDI-Public: 00613994384072
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/11/2021

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: 212243311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2021
• Initial Report FDA Received Date: 05/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1