BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE INJECTOR

    MDR report key: 6052926 · Received October 24, 2016

    Report

    Report Number
    8010047-2016-10015
    Event Type
    Malfunction
    Date Received
    October 24, 2016
    Date of Event
    October 5, 2016
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FBK
    PMA / PMN Number
    PK902736
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THE EXACT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED, IF ADDITIONAL AND SIGNIFICANT INFORMATION BECOMES AVAILABLE AT A LATER TIME.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THE NEEDLE TUBE WAS NOT CORRECTLY EXTENDED AND RETRACTED. THE SHEATH OF THE SUBJECT DEVICE WAS KINKED. AS THE RESULT OF CHECKING THE MANUFACTURING RECORD OF THE SAME LOT, THERE WERE NOTHING ABNORMAL FOUND. BASED ON THE SIMILAR CASES IN THE PAST, IT IS KNOWN THAT THE NEEDLE TUBE COULD NOT BE RETRACTED INTO THE SHEATH DUE TO KINK OF THE SHEATH. THE KINK OF THE SHEATH MIGHT BE CAUSED BY THE EXCESSIVE LOAD APPLIED TO THE SHEATH WHEN INSERTING THE SUBJECT DEVICE INTO THE ENDOSCOPE, TAKING OUT THE SUBJECT DEVICE FROM THE STERILE PACKAGE, OR IN CHECKING BEFORE USE. THE INSTRUCTION MANUAL OF THE SUBJECT DEVICE WARNS; WHEN INSERTING THE INSTRUMENT INTO THE ENDOSCOPE, RETRACT THE NEEDLE INTO THE SHEATH, HOLD THE INSTRUMENT CLOSE TO THE BIOPSY VALVE, AND KEEP IT AS STRAIGHT AS POSSIBLE RELATIVE TO THE BIOPSY VALVE. OTHERWISE, THE INSTRUMENT COULD BE DAMAGED. BEFORE USE, INSPECT THE INSERTION PORTION AND THE TUBE FOR DAMAGE.

    Description of Event or Problem · 1

    DURING A COLONOSCOPY AND POLYPECTOMY, THE NEEDLE TUBE OF THE SUBJECT DEVICE COULD NOT BE RETRACTED INTO THE SHEATH. IT WAS UNKNOWN WHETHER THE INTENDED PROCEDURE WAS COMPLETED OR NOT. BUT NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703127 SINGLE USE INJECTOR INJECTOR AND SHEATHSET FBK OLYMPUS MEDICAL SYSTEMS CORP. NM-400U-0423 K5407

    Patients

    Seq Age Sex Outcome Treatment
    1