MAUDE Adverse Event Report: MEDTRONIC XOMED INC. XPS® FOOTSWITCH; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Model Number	1895400
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for analysis.Analysis confirmed the reported event: ¿at rest/inactive and then turned on by itself.¿ the device was tested prior to repair.The pre-repair analysis indicated that the device had a broken cable.Device evaluation is not yet complete; completion of evaluation anticipated.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
It was reported that post-operative the footswitch was at rest/inactive and then turned on by itself.There was no patient impact.
Additional Manufacturer Narrative
The device analysis was completed.Service and repair replaced the broken cable.The device was tested to all manufacturing product specifications and returned to the customer.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Corrected information: no eval explain code.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received confirms that the footswitch "activate immediately when plugged in to the ipc".

• Brand Name: XPS® FOOTSWITCH
• 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: 6599713
• Report Number: 1045254-2017-00168
• Device Sequence Number: 10964685
• Product Code: ERL
• UDI-Device Identifier: 00681490048880
• UDI-Public: 00681490048880
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K963246
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/01/2017

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: 1895400
• Device Catalogue Number: 1895400
• Device Lot Number: 69399600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2017
• Supplement Date Received by Manufacturer: 08/09/2017; 08/09/2017; 08/20/2017
• Initial Report FDA Received Date: 05/30/2017
• Supplement Report FDA Received Date: 08/31/2017; 09/07/2017; 12/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1