BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOM 7MM EXTENDED LENGTH ENDOSCOPE

    MDR report key: 5535842 · Received March 30, 2016

    Report

    Report Number
    2242352-2016-00305
    Event Type
    Malfunction
    Date Received
    March 30, 2016
    Date of Event
    March 2, 2016
    Report Date
    March 3, 2016
    Manufacturer
    MAQUET CV
    Product Code
    GCJ
    PMA / PMN Number
    K014250
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS A REUSABLE OEM DEVICE; THEREFORE, A LOT HISTORY REVIEW IS NOT APPLICABLE . BASED ON THE SERIAL NUMBER PROVIDED AND A REVIEW OF THE SALES HISTORY TO THE ACCOUNT, THE DEVICE WAS SOLD TO THE ACCOUNT PRIOR TO 2009. A REVIEW OF THE CERTIFICATE OF CONFORMITY (C OF C) IS NOT APPLICABLE BECAUSE THIS EVENT OCCURRED WELL PAST THE SPECIFIED DEVICE LIFETIME RELIABILITY UNDER A 1-YEAR WARRANTY; 48 USES AT AVERAGE VOLUME AND 105 USES AT HIGH VOLUME.

    Description of Event or Problem · 1

    (B)(4). THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, BOM 7MM EXTENDED LENGTH ENDOSCOPE HAD SMUDGES ON THE LENS THAT MADE THE SCOPE UNUSABLE. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. NO REPLACEMENT DUE TO EXPIRED WARRANTY. (B)(4). GETTING READY TO START A CASE O.R. STAFF SAW A SMUDGES ON THE LENS THAT MADE THE SCOPE UNUSABLE. USED ANOTHER SCOPE TO COMPLETE.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, BOM 7MM EXTENDED LENGTH ENDOSCOPE HAD SMUDGES ON THE LENS THAT MADE THE SCOPE UNUSABLE. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. NO REPLACEMENT DUE TO EXPIRED WARRANTY. GETTING READY TO START A CASE O.R. STAFF SAW A SMUDGES ON THE LENS THAT MADE THE SCOPE UNUSABLE. USED ANOTHER SCOPE TO COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191581 BOM 7MM EXTENDED LENGTH ENDOSCOPE LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ MAQUET CV

    Patients

    Seq Age Sex Outcome Treatment
    1