BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE INJECTOR

    MDR report key: 3830427 · Received May 13, 2014

    Report

    Report Number
    8010047-2014-00245
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 14, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    KOG
    PMA / PMN Number
    K914496
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OMSC HAVE NOT RECEIVED THE SUBJECT PRODUCTS FOR EVALUATION YET. THE EXACT CAUSE OF THE USER'S REPORT COULD NOT BE CONCLUSIVELY DETERMINED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED, IF ADDITIONAL AND SIGNIFICANT INFORMATION BECOMES AVAILABLE AT A LATER TIME. THIS REPORT IS BEING SUBMITTED AS MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION. PLEASE CROSS REFERENCE: 8010047-2014-00243/00244/00246/00247.

    Additional Manufacturer Narrative · 1

    OLYMPUS MEDICAL SYSTEMS CORPORATION (OMSC) PERFORMED A MDR RETROSPECTIVE REVIEW AND OMSC FOUND THAT THIS SUPPLEMENTAL REPORT WAS REQUIRED. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE 3 OF 10 SUBJECT DEVICES WERE RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR INVESTIGATION. OMSC DID NOT GET THE INFORMATION FOR WHICH PROCEDURE THE 3 SUBJECT DEVICES WERE USED. THE INVESTIGATION CONFIRMED THAT THE NEEDLE OF EACH DEVICE COULD BE EXTENDED AND RETRACTED. BUT, WHILE THE NEEDLE OF THE EACH DEVICE WAS EXTENDED, INJECTION WAS NOT POSSIBLE. THE EACH NEEDLE TUBE WAS BUCKLED. AS THE RESULT OF CHECKING THE MANUFACTURING RECORD OF THE SAME LOT, THERE WAS NOTHING ABNORMAL DETECTED. BASED ON THE PAST SIMILAR CASES, THE NEEDLE COULD NOT BE RETRACTED AND THE NEEDLE COULD NOT INJECT A FLUID, BECAUSE THE NEEDLE TUBE MAY HAVE BEEN BUCKLED. THE NEEDLE WAS BUCKLED, BECAUSE THE FRICTION RESISTANCE BETWEEN THE OUTER TUBE AND THE NEEDLE TUBE MAY HAVE BEEN HIGH WHILE THE NEEDLE WAS EXTENDING. THE FRICTION RESISTANCE WAS HIGH, BECAUSE THE SLIDER MAY HAVE BEEN PUSHED ABRUPTLY. THE INSTRUCTION MANUAL OF THE SUBJECT DEVICE WARNS; *STRAIGHTEN OUT THE INSTRUMENT BEFORE INSPECTING IT. THE INSTRUMENT CAN BE DAMAGED IF IT IS COILED WHILE THE HANDLE IS OPERATED. *OPERATE THE SLIDER SLOWLY, OTHERWISE THE TUBE COULD BUCKLE. *DO NOT PUSH THE SLIDER ABRUPTLY, OTHERWISE THE NEEDLE WILL BE RAPIDLY EXTENDED FROM THE DISTAL END OF THE TUBE. THIS COULD RESULT IN PATIENT INJURY, SUCH AS PERFORATION, BLEEDING OR MUCOUS MEMBRANE DAMAGE. IT COULD ALSO DAMAGE THE INSTRUMENT. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION. PLEASE CROSS REFERENCE THE ASSOCIATED COMPLAINT FILES: MFR REPORT: #8010047-2014-00243/00244/00246/00247.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP (OMSC) WAS INFORMED THAT DURING UNSPECIFIED PROCEDURE, THE NEEDLE COULD NOT BE RETRACTED INTO THE SHEATH. ALL FIVE DEVICES FROM THE BOX FAILED. THE DOCTOR COMPLETED PROCEDURE BY USING A SIMILAR DEVICE. THERE WAS NO REPORT OF PATIENT INJURY REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285488 SINGLE USE INJECTOR INJECTION NEEDLE KOG OLYMPUS MEDICAL SYSTEMS CORPORATION NM-401L-0623 3XK

    Patients

    Seq Age Sex Outcome Treatment
    1