BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOM 7MM EXTENDED LENGTH ENDOSCOPE

    MDR report key: 8443461 · Received March 22, 2019

    Report

    Report Number
    2242352-2019-00337
    Event Type
    Malfunction
    Date Received
    March 22, 2019
    Report Date
    March 20, 2019
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GCJ
    PMA / PMN Number
    K014250
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT NUMBER: (B)(4). AUTONUMBER: (B)(4). THIS IS A REUSABLE OEM DEVICE; THEREFORE, A SERIAL HISTORY REVIEW WAS NOT APPLICABLE. THE CERTIFICATE OF CONFORMANCE (C OF C) WAS REVIEWED. THE VENDOR CERTIFIES THAT THIS DEVICE SERIAL CONFORMS TO ALL APPLICABLE PRODUCT SPECIFICATIONS. THE DEVICE WAS RETURNED TO THE FACTORY FOR INVESTIGATION. SIGNS OF CLINICAL USE WAS OBSERVED. THERE WAS NO EVIDENCE OF BLOOD DETECTED. THERE WERE NO VISUAL DEFECTS DETECTED. THE CUSTOMER MADE REFERENCE TO THE LIGHT ADAPTOR OF THE ENDOSCOPE BEING BROKEN OFF. THE LIGHT ADAPTOR IS DESIGNED TO BE UNSCREWED FROM THE DEVICE BY TWISTING IT COUNTER CLOCKWISE. THE LIGHT ADAPTOR WAS RETURNED WITH THE ENDOSCOPE. THERE WERE NO DEFECTS DETECTED WITH THE ENDOSCOPE. BASED ON THE RETURNED CONDITION OF THE DEVICE, AND THE RESULTS OF THE INVESTIGATION, THE REPORTED FAILURE "BREAK" IS NOT CONFIRMED.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, BOM 7MM EXTENDED LENGTH ENDOSCOPE LIGHT ADAPTER BROKE OFF . A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RETURNED TO THE FACTORY AND IS BEING EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, BOM 7MM EXTENDED LENGTH ENDOSCOPE LIGHT ADAPTER BROKE OFF . A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235552 BOM 7MM EXTENDED LENGTH ENDOSCOPE LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ MAQUET CARDIOVASCULAR LLC

    Patients

    Seq Age Sex Outcome Treatment
    1