BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOM 7MM EXTENDED LENGTH ENDOSCOPE

    MDR report key: 6096101 · Received November 11, 2016

    Report

    Report Number
    2242352-2016-01144
    Event Type
    Malfunction
    Date Received
    November 11, 2016
    Date of Event
    October 19, 2016
    Report Date
    October 20, 2016
    Manufacturer
    MAQUET CV
    Product Code
    GCJ
    PMA / PMN Number
    K014250
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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.

    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 NO 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 ABLE TO BE OBTAINED. CONDENSATION WAS NOT 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 NOT CONFIRMED FOR THE REPORTED FAILURE "POOR QUALITY IMAGE".

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING STERILIZATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, BOM 7MM EXTENDED LENGTH ENDOSCOPE S/N (B)(4) LENS WERE FOGGY. WARRANTY WILL EXPIRE 6/15/17. 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 STERILIZATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, BOM 7MM EXTENDED LENGTH ENDOSCOPE S/N (B)(4) LENS WERE FOGGY. WARRANTY WILL EXPIRE 6/15/17. 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
    748135 BOM 7MM EXTENDED LENGTH ENDOSCOPE LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ MAQUET CV

    Patients

    Seq Age Sex Outcome Treatment
    1