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

Model Number	1895410
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Patient Involvement (2645)
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.¿ analysis indicated that the device had a broken cable.As requested by the customer, the device was sent back to the customer un-repaired.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 facility reported that during set up the device was at rest/inactive and then activated by itself.There was no patient involvement.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received indicating that the foot control activated immediately when plugged into the integrated power console (ipc).A manual switch was used to complete the surgery.The event occurred at the beginning of (b)(6).

• 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: 6667041
• Report Number: 1045254-2017-00207
• Device Sequence Number: 13657171
• Product Code: ERL
• UDI-Device Identifier: 00681490048941
• UDI-Public: 00681490048941
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2017

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: 1895410
• Device Catalogue Number: 1895410
• Device Lot Number: 67006000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2017
• Supplement Date Received by Manufacturer: 06/26/2017
• Initial Report FDA Received Date: 06/26/2017
• Supplement Report FDA Received Date: 07/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1