BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOM 7MM EXTENDED LENGTH ENDOSCOPE

    MDR report key: 5534389 · Received March 30, 2016

    Report

    Report Number
    2242352-2016-00296
    Event Type
    Malfunction
    Date Received
    March 30, 2016
    Report Date
    March 2, 2016
    Manufacturer
    MAQUET CV
    Product Code
    GCJ
    PMA / PMN Number
    K014250
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATE 03/29/2016 10:30 AM (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 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

    UPDATE 03/04/2016 02:58 PM (B)(4): THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, BOM 7MM EXTENDED LENGTH ENDOSCOPE COULD NOT GET A FULL IMAGE. THE PICTURE WAS FINE BUT IT WAS OFF CENTERED. POSSIBLY, THE FIRST LENS CAME LOOSE. ******************************************************************************************* ON (B)(6) 2016 06:02 PM: DURING USE, THE SURGEON COULD NOT GET A FULL IMAGE. THE PICTURE WAS FINE, BUT IT WAS OFF CENTERED. (B)(6), SURGICAL INSTRUMENT TECHNICIAN, LOOKED AT IT AND THE EYEPIECE LOOKED A LITTLE OFF CENTER. HE THINKS THE FIRST LENS CAME LOOSE.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, BOM 7MM EXTENDED LENGTH ENDOSCOPE COULD NOT GET A FULL IMAGE. THE PICTURE WAS FINE BUT IT WAS OFF CENTERED. POSSIBLY, THE FIRST LENS CAME LOOSE. DURING USE, THE SURGEON COULD NOT GET A FULL IMAGE. THE PICTURE WAS FINE, BUT IT WAS OFF CENTERED. BOB MANNING, SURGICAL INSTRUMENT TECHNICIAN, LOOKED AT IT AND THE EYEPIECE LOOKED A LITTLE OFF CENTER. HE THINKS THE FIRST LENS CAME LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190801 BOM 7MM EXTENDED LENGTH ENDOSCOPE LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ MAQUET CV

    Patients

    Seq Age Sex Outcome Treatment
    1