BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOM 7MM EXTENDED LENGTH ENDOSCOPE

    MDR report key: 5514354 · Received March 21, 2016

    Report

    Report Number
    2242352-2016-00256
    Event Type
    Injury
    Date Received
    March 21, 2016
    Date of Event
    February 22, 2016
    Report Date
    February 23, 2016
    Manufacturer
    MAQUET CV
    Product Code
    GCJ
    PMA / PMN Number
    K014250
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2016 10:05 AM (GMT-4:00) ADDED BY (B)(4): THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS A REUSABLE OEM DEVICE; THEREFORE, A LOT HISTORY REVIEW WAS NOT APPLICABLE. THE PRODUCT IS NOT RETURNING. A SERIAL NUMBER WAS NOT PROVIDED FOR THIS DEVICE, THEREFORE IT IS IMPOSSIBLE TO OBTAIN A CERTIFICATE OF CONFORMANCE.

    Description of Event or Problem · 1

    ON (B)(4) 2016 11:54 AM (GMT-5:00) ADDED BY (B)(4)): THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, BOM 7MM EXTENDED LENGTH ENDOSCOPE LIGHT CORD WHICH CONNECTS TO THE SCOPE BECAME DISCONNECTED FROM THE SCOPE. THEN, THE LIGHT CORD STARTED A FIRE ON THE TABLE WHICH BURNED THE PATIENT. ON (B)(4) 2016 12:36 AM (GMT-5:00) ADDED BY (B)(4): DURING THE EVH CASE, THE LIGHT CORD, WHICH CONNECTS TO THE VH1111 SCOPE, BECAME DISCONNECTED, THEN THE LIGHT CORD STARTED A FIRE ON THE TABLE, WHICH BURNED THE PATIENT. THE HOSPITALS EMAIL NOTIFICATION IS BELOW:

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, BOM 7MM EXTENDED LENGTH ENDOSCOPE LIGHT CORD WHICH CONNECTS TO THE SCOPE BECAME DISCONNECTED FROM THE SCOPE. THEN, THE LIGHT CORD STARTED A FIRE ON THE TABLE WHICH BURNED THE PATIENT. DURING THE EVH CASE, THE LIGHT CORD, WHICH CONNECTS TO THE VH1111 SCOPE, BECAME DISCONNECTED, THEN THE LIGHT CORD STARTED A FIRE ON THE TABLE, WHICH BURNED THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169574 BOM 7MM EXTENDED LENGTH ENDOSCOPE LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ MAQUET CV

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other