BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOM 7MM EXTENDED LENGTH ENDOSCOPE

    MDR report key: 5441893 · Received February 17, 2016

    Report

    Report Number
    2242352-2016-00150
    Event Type
    Malfunction
    Date Received
    February 17, 2016
    Date of Event
    November 11, 2015
    Report Date
    November 12, 2015
    Manufacturer
    MAQUET CV
    Product Code
    GCJ
    PMA / PMN Number
    K014250
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (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).

    Description of Event or Problem · 1

    (B)(4). THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, BOM 7MM EXTENDED LENGTH ENDOSCOPE BECAME DARK DUE TO THE SCOPE NOT EMITTING LIGHT IN THE TUNNEL. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. (B)(4). EVH TUNNEL BECAME DARK DUE TO SCOPE NOT EMITTING LIGHT IN THE TUNNEL. PA HAD TO STOP THE PROCEDURE AND FINISH CASE USING COMPETITIVE (TERUMO) SCOPE AND HARVESTING KIT.

    Description of Event or Problem · 1

    (B)(4). THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, BOM 7MM EXTENDED LENGTH ENDOSCOPE BECAME DARK DUE TO THE SCOPE NOT EMITTING LIGHT IN THE TUNNEL. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. (B)(4): EVH TUNNEL BECAME DARK DUE TO SCOPE NOT EMITTING LIGHT IN THE TUNNEL. PA HAD TO STOP THE PROCEDURE AND FINISH CASE USING COMPETITIVE (TERUMO) SCOPE AND HARVESTING KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99260 BOM 7MM EXTENDED LENGTH ENDOSCOPE LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ MAQUET CV

    Patients

    Seq Age Sex Outcome Treatment
    1