BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYF HND SWTCH PENCL AUTOCLAVAB

    MDR report key: 7175842 · Received January 9, 2018

    Report

    Report Number
    1320894-2018-00002
    Event Type
    Malfunction
    Date Received
    January 9, 2018
    Date of Event
    December 15, 2017
    Report Date
    January 9, 2018
    Manufacturer
    CONMED CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K001159
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE WAS DISCARDED BY THE USER FACILITY DUE TO BIOMATERIAL ON THE DEVICE; THEREFORE, AN EVALUATION IS UNABLE TO BE PERFORMED. A REVIEW OF THE MANUFACTURING DOCUMENTS WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER WAS NOT PROVIDED. A TWO-YEAR HISTORICAL COMPLAINT REVIEW REVEALED ONE PRIOR COMPLAINT RELATED TO THIS FAILURE FOR THIS PRODUCT. IN THAT SAME TIMEFRAME, (B)(4) DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. THE CLINICAL DATA REPORT (CDR) STATES THAT WHEN USED UNDER THE CONDITIONS AND FOR THE PURPOSES INTENDED THAT THE UNDESIRABLE SIDE EFFECTS, UNDER NORMAL CONDITIONS OF USE, ARE ACCEPTABLE WHEN WEIGHED AGAINST THE BENEFITS TO THE PATIENTS. THE INSTRUCTIONS FOR USE ADVISE THE USER OF THE FOLLOWING. -DO NOT USE THE DEVICE IF ANY SIGNS OF CRACKS, CUTS, PUNCTURES, NICKS OR ABRASION ARE VISIBLE. -PROLONGED USE OF THE HANDPIECE CAUSES THE ELECTRODE TO BECOME VERY HOT AND THE TIP REMAINS HOT FOR A PERIOD AFTER USE. -DO NOT ALLOW THE TIP TO COME IN CONTACT WITH THE PATIENT OR OTHERS AFTER ACTIVATION TO AVOID BURNS. THIS INCIDENT TYPE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED DURING A 7-900-5 PENCIL "SPARKED AND CAUGHT FIRE AT THE PIN CONNECTOR". THIS INCIDENT OCCURRED DURING PRE-OP TESTING; THEREFORE, NO PATIENT CONTACT. THIS REPORT IS RAISED ON THE BASIS OF A REPORTED DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY WITH RECURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17886 HYF HND SWTCH PENCL AUTOCLAVAB HYFRECATOR ACCESSORIES GEI CONMED CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1