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	08/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned.However, the product analysis results are pending completion of the evaluation.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported that during setup, when the handpiece was at rest/inactive and the foot switch was released, the handpiece turned on by itself.Also, when using the foot switch, there was no action from the console.There was no patient impact or injury.
Additional Manufacturer Narrative
The product analysis indicates that an intermittent connection was observed.The cable assembly had an electrical short.The cable assembly was replaced, tested, and passed to manufacturing specifications.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: 6868407
• Report Number: 1045254-2017-00319
• Device Sequence Number: 16308460
• 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: Medical Technologist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2017

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: 1898430
• Device Catalogue Number: 1898430
• Device Lot Number: 209234051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2017
• Supplement Date Received by Manufacturer: 10/10/2017
• Initial Report FDA Received Date: 09/15/2017
• Supplement Report FDA Received Date: 10/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1