BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOM 7MM EXTENDED LENGTH ENDOSCOPE

    MDR report key: 8233896 · Received January 10, 2019

    Report

    Report Number
    2242352-2019-00044
    Event Type
    Malfunction
    Date Received
    January 10, 2019
    Date of Event
    December 17, 2018
    Report Date
    January 9, 2019
    Manufacturer
    MAQUET CV
    Product Code
    GCJ
    PMA / PMN Number
    K014250
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT # TRACKWISE # (B)(4). AUTONUMBER # (B)(4). THIS IS A REUSABLE OEM DEVICE; THEREFORE, A SERIAL NUMBER REVIEW WAS NOT APPLICABLE. A SERIAL NUMBER WAS NOT PROVIDED AND THE SPECIFIC PRODUCT SERIAL NUMBER CANNOT BE IDENTIFIED FROM A SHIP HISTORY, THEREFORE IT IS IMPOSSIBLE TO OBTAIN A CERTIFICATE OF CONFORMANCE.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, BOM 7MM EXTENDED LENGTH ENDOSCOPE WAS CAUSING THE CONICAL TIP TO FRAY. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    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 PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, BOM 7MM EXTENDED LENGTH ENDOSCOPE WAS CAUSING THE CONICAL TIP TO FRAY. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25922 BOM 7MM EXTENDED LENGTH ENDOSCOPE LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ MAQUET CV

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR