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

Model Number	EF200RF
Medical Device Problem Code	Device Remains Activated (1525)
Health Effect - Clinical Code	Injury (2348)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Submitting this regulatory report in reference to medwatch form #: 1625507-2018-00080.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A health care provider (hcp) reported via a manufacturer representative that the foot pedal malfunctioned and caused patient harm during the procedure.The hcp also noted that the perforator kept spinning with no pressure on the foot pedal.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
On follow up, it was reported that the drill did not shut off and the motor and perforator continued to drill into the sinus.It was also confirmed that the patient suffered a small, non-clinically relevant stroke after surgery.No further information was provided on the patient current status.
Additional Manufacturer Narrative
"review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803." if information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Mdr decision corrected to not reportable.No additional supplementals required unless additional information received indicates reportable event.

• 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: 8203218
• Report Number: 1045254-2018-00745
• Device Sequence Number: 1656823
• Product Code: HBE
• UDI-Device Identifier: 00643169931480
• UDI-Public: 00643169931480
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: EF200RF
• Device Catalogue Number: EF200RF
• Device Lot Number: 215110380
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2018
• Supplement Date Received by Manufacturer: 01/28/2019; 04/30/2019
• Initial Report FDA Received Date: 12/28/2018
• Supplement Report FDA Received Date: 02/27/2019; 05/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN PERFORATOR, SERIAL #: UNKNOWN
• Outcome Attributed to Adverse Event: Other