BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOM 7MM EXTENDED LENGTH ENDOSCOPE

    MDR report key: 6087563 · Received November 8, 2016

    Report

    Report Number
    2242352-2016-01102
    Event Type
    Malfunction
    Date Received
    November 8, 2016
    Report Date
    October 11, 2016
    Manufacturer
    MAQUET CV
    Product Code
    GCJ
    PMA / PMN Number
    K014250
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS A REUSABLE OEM DEVICE; THEREFORE, A LOT HISTORY REVIEW WAS NOT APPLICABLE. THE CERTIFICATE OF CONFORMANCE (C OF C) WAS REVIEWED. THE VENDOR CERTIFIES THAT THIS DEVICE LOT CONFORMS TO ALL APPLICABLE PRODUCT SPECIFICATIONS. THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. SIGNS OF CLINICAL USE AND EVIDENCE OF BLOOD WERE OBSERVED. A VISUAL INSPECTION WAS CONDUCTED. NO VISUAL DEFECTS WERE OBSERVED. AN IMAGE QUALITY INSPECTION WAS PERFORMED WITH AN ENDOSCOPIC VIDEO IMAGING SYSTEM. A CLEAR IMAGE WAS UNABLE TO BE OBTAINED. CONDENSATION WAS OBSERVED ON THE INSIDE OF THE LENS WHEN THE DEVICE WAS OUT OF FOCUS. BASED ON THE RESULTS OF THE EVALUATION, THE REPORTED COMPLAINT WAS CONFIRMED FOR THE REPORTED FAILURE "POOR QUALITY IMAGE".

    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.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, BIOMED RECEIVED BOM 7MM EXTENDED LENGTH ENDOSCOPE S/N (B)(4) FOR REPAIR. IT WAS NOTICED THAT MOISTURE WAS IN THE LENS AND A BLURRY PICTURE ON MONITOR. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, BIOMED RECEIVED BOM 7MM EXTENDED LENGTH ENDOSCOPE S/N (B)(4) FOR REPAIR. IT WAS NOTICED THAT MOISTURE WAS IN THE LENS AND A BLURRY PICTURE ON MONITOR. 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
    736365 BOM 7MM EXTENDED LENGTH ENDOSCOPE LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ MAQUET CV

    Patients

    Seq Age Sex Outcome Treatment
    1