BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRONCHOVIDEOSCOPE

    MDR report key: 15564441 · Received October 7, 2022

    Report

    Report Number
    9610595-2022-02723
    Event Type
    Malfunction
    Date Received
    October 7, 2022
    Report Date
    December 5, 2022
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    EOQ
    UDI-DI
    04953170288968
    PMA / PMN Number
    K023984
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 11 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, IT¿S LIKELY THE COATING OF THE INSERTION SECTION PEELED DUE TO PHYSICAL STRESS. THE ROOT CAUSE OF THIS EVENT WAS UNABLE TO BE IDENTIFIED. THE EVENT CAN BE DETECTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: ¿PREPARATION AND INSPECTION_ INSPECTION OF THE ENDOSCOPE INSPECT THE EXTERNAL SURFACE OF THE ENTIRE INSERTION TUBE INCLUDING THE BENDING SECTION AND THE DISTAL END FOR DENTS, BULGES, SWELLING, PEELING, SCRATCHING, HOLES, SAGGING, TRANSFORMATION, BENDS, ADHESION OF FOREIGN BODY, DROPOUT OF PARTS, ANY PROTRUDING OBJECTS OR OTHER IRREGULARITIES.¿ THE EVENT CAN BE PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: ¿IMPORTANT INFORMATION ¿ PLEASE READ BEFORE USE WARNING: DO NOT STRIKE, BEND, HIT, PULL, TWIST, OR DROP THE ENDOSCOPE¿S DISTAL END, INSERTION TUBE, BENDING SECTION, CONTROL SECTION, UNIVERSAL CORD, OR ENDOSCOPE CONNECTOR WITH EXCESSIVE FORCE. THE ENDOSCOPE MAY BE DAMAGED AND COULD CAUSE PATIENT INJURY, SUCH AS BURNS, BLEEDING, AND/OR PERFORATION. IT COULD ALSO CAUSE PARTS OF THE ENDOSCOPE TO FALL OFF INSIDE THE PATIENT.¿ OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    FULL NAME OF THE FACILITY IS HEALTHCARE GLOBAL ENTERPRISES LTD. UNIT OF HCG MEDISURGE HOSPITAL PVT. LTD. THE DEVICE IS RETURNED AND AN EVALUATION COMPLETED FOR IT. UPON INSPECTION OF THE DEVICE, IT WAS OBSERVED THAT THE COATING OF THE CONNECTING TUBE WAS PEELING MORE THAN 1 MILLIMETER SQUARE AREA OR MORE. OTHER OBSERVATIONS FOR THE DEVICE ARE: DUE TO PINHOLE ON DISTAL END RUBBER COATING (A-RUBBER), WATER TIGHTNESS IS LOST; DISTAL END, CONTROL UNIT, AND UNIVERSAL CORD HAVE A SCRATCH; ADHESIVE ON A-RUBBER IS DETACHED; CONNECTING TUBE HAS A DENT; AND ANGULATION IS LOW. EVALUATION IS ONGOING. SUPPLEMENTAL REPORT(S) WILL BE SUBMITTED WHEN ANY RELEVANT NEW INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    CUSTOMER RETURNED THE DEVICE FOR EVALUATION AND REPAIR FOR A DISTAL END RUBBER COATING (A-RUBBER) LEAKAGE ISSUE. THERE IS NO REPORTED HARM TO ANY PATIENT. UPON EVALUATION OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THE COATING OF THE CONNECTING TUBE WAS PEELING MORE THAN 1 MILLIMETER SQUARE AREA OR MORE. THIS MEDWATCH IS BEING SUBMITTED FOR THE REPORTABLE ISSUE OF THE CONNECTING TUBE PEELING MORE THAN 1 MILLIMETER SQUARE AREA OR MORE OBSERVED DURING DEVICE EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2897807 BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ AIZU OLYMPUS CO., LTD. BF-1T150 04953170288968

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown