BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERBE APC HANDLE

    MDR report key: 17217412 · Received June 28, 2023

    Report

    Report Number
    9610614-2023-00038
    Event Type
    Malfunction
    Date Received
    June 28, 2023
    Date of Event
    June 25, 2021
    Report Date
    June 28, 2023
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K003462
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO ERBE FOR AN EVALUATION. THE PROVIDED INVESTIGATION REPORT STATED THAT "THE KEYS OF THE ACCESSORIES WERE LOST AND THE IMPROPER TRANSPORTATION PROCESS LED TO THE LOOSENING OF THE KEYS DUE TO EXTERNAL IMPACT. THE INTEGRITY OF THE SURGICAL INSTRUMENTS SHOULD BE CHECKED BEFORE THE OPERATION AND THEY SHOULD BE CAREFULLY AND GENTLY PLACED DURING TRANSPORTATION." OUR UNDERSTANDING OF THIS CONCLUSION IS THAT THE BUTTON ON THE APC HANDLE HAD BECOME DETACHED DUE TO MISHANDLING. PER HANDLE'S NOTES ON USE, THE ACCESSORY IS TO CHECKED AND TESTED PRIOR TO USE AND PROTECTED FROM ANY FORM OF MECHANICAL DAMAGE. ERBE USA, INC. IS NOW CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT INCIDENT OCCURRED DURING A THORACIC SURGERY. AN ARGON PLASMA COAGULATOR (MODEL NOT REPORTED) WAS BEING USED WITH THE ERBE APC HANDLE. NO OTHER INFORMATION WAS PROVIDED REGARDING ANY OTHER ACCESSORY USED OR THE EQUIPMENT SETTINGS. DURING THE PROCEDURE, IT WAS DISCOVERED THAT A BUTTON ON THE HANDLE WAS NOT PRESENT. THEREFORE, MEDICAL PERSONNEL SEARCHED FOR THE MISSING BUTTON, BUT IT COULD NOT BE FOUND. BEFORE CLOSING THE PATIENT'S CHEST CAVITY, THE SURGEONS FLUSHED THE INCISION SITE AND CONFIRMED THAT THE BUTTON WAS NOT INSIDE THE PATIENT. AFTER COMPLETING THE PROCEDURE, BEDSIDE RADIOGRAPHIC IMAGING WAS PERFORMED ON THE PATIENT DEMONSTRATING THAT THERE WAS "NO FOREIGN BODY IN THE RIGHT THORACIC CAVITY. THE PATIENT WAS THEN SENT BACK TO THE ICU."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1783003 ERBE APC HANDLE APC HANDLE GEI ERBE ELEKTROMEDIZIN GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Other