BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPC® FOOTPEDAL

    MDR report key: 5471552 · Received March 1, 2016

    Report

    Report Number
    1045254-2016-00057
    Event Type
    Malfunction
    Date Received
    March 1, 2016
    Report Date
    February 2, 2016
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ERL
    PMA / PMN Number
    K081277
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    DATE RECEIVED BY MFR: MAY 4, 2015. THE PRODUCT ANALYSIS FOR THE FOOT SWITCH WITH SERIAL NUMBER (B)(4), INDICATES THAT THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE CORSET WAS REPLACED DUE TO CUT CABLE INSULATION AND THE WORN SAFETY TAPE WAS REPLACED. THE DEVICE WAS TESTED AND PASSED ALL MANUFACTURING SPECIFICATIONS. (B)(4).

    Additional Manufacturer Narrative · 1

    BOTH FOOT SWITCHES WERE RETURNED AT THE SAME TIME AND THE COMPLAINANT DID NOT KNOW WHICH ISSUE OCCURRED WITH EACH FOOT SWITCH. THEREFORE, THE DETAILS OF BOTH FOOT SWITCHES WILL BE INCLUDED. DETAILS OF THE SECOND FOOT SWITCH ARE LISTED BELOW: 1898430 FOOT SWITCH; SERIAL NUMBER - (B)(4); LOT NUMBER - 62309400; MANUFACTURE DATE ¿ JUNE 3, 2009; 510K NUMBER - K081277. PATIENT CODE: NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT; DEVICE CODE: SELF-ACTIVATION OR KEYING. THE TWO FOOT SWITCHES HAVE BEEN RETURNED. HOWEVER, THE PRODUCT ANALYSIS FOR EACH FOOT SWITCH HAS NOT BEEN COMPLETED. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES.

    Additional Manufacturer Narrative · 1

    THE PRODUCT ANALYSIS FOR THE FOOT SWITCH, SERIAL NUMBER (B)(4), WAS COMPLETED ON APRIL 1, 2016. THE PRODUCT ANALYSIS INDICATES THAT THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE FOOT SWITCH WAS TESTED AND PASSED ALL MANUFACTURING SPECIFICATIONS. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ISSUES WITH TWO FOOT SWITCHES THAT TOOK PLACE IN TWO SEPARATE CASES. ONE FOOT SWITCH WAS NOT BEING RECOGNIZED BY THE CONSOLE. THE USER EXPERIENCED UNINTENDED ACTIVATION WITH THE SECOND FOOT SWITCH. INTRAOPERATIVE, THE USER LAID THE HANDPIECE DOWN ON A TABLE AND THE HANDPIECE ENGAGED THE BLADE ATTACHMENT ON ITS OWN (UNINTENDED ACTIVATION). BOTH FOOT SWITCHES WERE RETURNED AT THE SAME TIME AND THE COMPLAINANT DID NOT KNOW WHICH ISSUE OCCURRED WITH EACH FOOT SWITCH. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126964 IPC® FOOTPEDAL DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL MEDTRONIC XOMED INC. 1898430 62115800

    Patients

    Seq Age Sex Outcome Treatment
    1