BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENCIL, H2K, PUSHBUTTON

    MDR report key: 10884573 · Received November 23, 2020

    Report

    Report Number
    3007305485-2020-00522
    Event Type
    Malfunction
    Date Received
    November 23, 2020
    Date of Event
    October 26, 2020
    Report Date
    January 12, 2020
    Manufacturer
    CONSOLIDATED MEDICAL EQUIPMENT
    Product Code
    GEI
    PMA / PMN Number
    K001159
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AND NO PHOTOGRAPHIC EVIDENCE HAS BEEN PROVIDED; THEREFORE, THE REPORTED EVENT CANNOT BE VERIFIED. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THE PRODUCT. THE PRODUCT RELEASED FOR DISTRIBUTION WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. THIS IS THE ONLY COMPLAINT FOR THIS LOT NUMBER AND FAILURE MODE WITHIN THE PAST TWO YEARS. (B)(4). PER THE INSTRUCTIONS FOR USE, 62-6108-001, THE USER IS ADVISED THAT THE DEVICE SHOULD NEVER BE USED WHEN: THERE IS VISIBLE EVIDENCE OF DAMAGE TO THE EXTERIOR OF THE DEVICE, SUCH AS CRACKS, CUTS, PUNCTURES, NICKS, ABRASIONS, DISCOLORATION OR CONNECTOR DAMAGE. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION AND REVIEW. HOWEVER, THE COMPLAINT INVESTIGATION IS NOT COMPLETE AT THIS TIME. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE COMPLAINT INVESTIGATION. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE, 7-900-5, WAS BEING USED DURING PRE-OP TESTING BEFORE AN UNKNOWN DERMATOLOGY PROCEDURE ON (B)(6) 2020 WHEN IT WAS REPORTED "I WENT TO PRESS THE CAUTERY BUTTON AND IT DIDN'T WORK. IT LATER WORKED AND HAD ALREADY BURNED SOME LESIONS AND WHEN I PRESSED THE BUTTON AGAIN, THE CAUTERY STOPPED WORKING. WHEN I LOOKED AT THE MACHINE AND THE PENCIL TO SEE IF I HAD LOWERED THE INTENSITY OF THE CAUTERY WITHOUT REALIZING IT, I SAW THAT THERE WAS A SMALL ELECTRICAL PANEL PROTRUDING FROM UNDER THE PENCIL, SO I QUICKLY RE-INSERTED IT INTO THE PENCIL. THAT'S WHEN HE STUMBLED AND NEITHER WENT IN NOR OUT. IT SEEMS THAT THE CAP BETWEEN THE BODY OF THE PENCIL AND THE CABLE CAME OFF AND WHAT GOES INSIDE THE PENCIL CAME OFF, WHICH IS A SMALL ELECTRICAL PANEL WITH LITTLE CABLES." FURTHER INFORMATION RECEIVED FOUND THAT THE DEVICE WAS NEVER USED ON THE PATIENT. THE PROCEDURE WAS REPORTED AS HAVING NOT BEEN COMPLETED WITH NO REASON GIVEN. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION OR HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1349878 PENCIL, H2K, PUSHBUTTON ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONSOLIDATED MEDICAL EQUIPMENT 19320023

    Patients

    Seq Age Sex Outcome Treatment
    1