BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOM 7MM EXTENDED LENGTH ENDOSCOPE

    MDR report key: 8458087 · Received March 27, 2019

    Report

    Report Number
    2242352-2019-00363
    Event Type
    Malfunction
    Date Received
    March 27, 2019
    Date of Event
    March 4, 2019
    Report Date
    March 27, 2019
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GCJ
    PMA / PMN Number
    K014250
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED G5 - CHANGED PMA/510(K)# FROM K052274 TO K014250. INTERNAL COMPLAINT # TRACKWISE # (B)(4). AUTONUMBER # (B)(4). THIS IS A REUSABLE OEM DEVICE; THEREFORE, A LOT HISTORY REVIEW WAS NOT APPLICABLE. THE CERTIFICATE OF CONFORMANCE (C OF C) WAS REVIEWED. THE VENDOR CERTIFIES THAT THIS DEVICE LOT CONFORMS TO ALL APPLICABLE PRODUCT SPECIFICATIONS.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING STERILIZATION/SANITIZATION, THEY NOTICED A DAMAGED SCOPE AND CALLED FOR REPAIR/SERVICE INFORMATION. NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    (B)(4). SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVALUATION CANNOT BE PERFORMED. PER OUR STANDARD SOP'S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING STERILIZATION/SANITIZATION, THEY NOTICED A DAMAGED SCOPE AND CALLED FOR REPAIR/SERVICE INFORMATION. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248039 BOM 7MM EXTENDED LENGTH ENDOSCOPE LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ MAQUET CARDIOVASCULAR LLC

    Patients

    Seq Age Sex Outcome Treatment
    1