BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE INJECTOR

    MDR report key: 6699846 · Received July 10, 2017

    Report

    Report Number
    8010047-2017-00846
    Event Type
    Malfunction
    Date Received
    July 10, 2017
    Date of Event
    June 29, 2017
    Report Date
    September 12, 2017
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FBK
    PMA / PMN Number
    PK902736
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A SUPPLEMENTAL REPORT FOR MFR REPORT # 8010047-2017-00846 TO PROVIDE ADDITIONAL INFORMATION BASED ON THE EVALUATION OF THE DEVICE. LOT # WAS CORRECTED. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC). OMSC INVESTIGATED IT ON SEPTEMBER 11, 2017. THE NEEDLE OF THE SUBJECT DEVICE REMAINED TO BE RETRACTED INTO THE SHEATH. THE NEEDLE COULD NOT BE EXTENDED FROM THE SHEATH. THE SHEATH AND THE NEEDLE TUBE WERE KINKED AT ABOUT 55 MM AND 110 MM FROM THE DISTAL END OF THE SHEATH. THE NEEDLE TUBE WAS COMPRESSIVE BUCKLED. THE MANUFACTURING RECORD WAS REVIEWED AND FOUND NO IRREGULARITIES. BASED ON THE PAST SIMILAR CASES, IT WAS KNOWN THAT EXCESSIVE LOAD WAS APPLIED TO THE SHEATH AND THE NEEDLE TUBE WHEN THE SUBJECT DEVICE WAS INSERTED INTO THE ENDOSCOPE, TAKEN OUT FROM THE STERILE PACKAGE, OR CHECKED BEFORE USE, AND THEN THE SHEATH AND THE NEEDLE TUBE WERE KINKED. DUE TO THE KINKS, FRICTION RESISTANCE BETWEEN THE SHEATH AND THE NEEDLE TUBE BECAME LARGE, AND THE NEEDLE COULD NOT BE RETRACTED INTO THE SHEATH. BECAUSE FRICTION RESISTANCE BETWEEN THE SHEATH AND THE NEEDLE TUBE WAS LARGE, THE COMPRESSIVE BUCKLING OCCURRED WHEN THE NEEDLE WAS EXTENDED FROM THE SHEATH. THE INSTRUCTION MANUAL OF THE DEVICE HAS ALREADY WARNED AS FOLLOWS; WARNINGS: OPERATE THE SLIDER SLOWLY, OTHERWISE THE TUBE COULD BUCKLE. STRAIGHTEN OUT THE INSTRUMENT BEFORE INSPECTING IT. THE INSTRUMENT CAN BE DAMAGED IF IT IS COILED WHILE THE HANDLE IS OPERATED.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IN THIS REPORT HAS NOT YET BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE OR IF THE DEVICE IS RETURNED AT A LATER TIME, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    DURING A MUCOSECTOMY, THE NEEDLE OF THE SUBJECT DEVICE USED FOR THE INJECTION OF NACL COULD NOT BE RETRACTED INTO THE TUBE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478154 SINGLE USE INJECTOR INJECTOR AND SHEATHSET FBK OLYMPUS MEDICAL SYSTEMS CORP. NM-401L-0423 K6901

    Patients

    Seq Age Sex Outcome Treatment
    1