BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE LIGATING DEVICE

    MDR report key: 3173500 · Received June 12, 2013

    Report

    Report Number
    8010047-2013-00151
    Event Type
    Malfunction
    Date Received
    June 12, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 14, 2013
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    MND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OMSC FOLLOWED UP WITH THE USER FACILITY TO OBTAIN MORE DETAILED INFO. IT WAS REPORTED THAT THE FACILITY SUCCESSFULLY COULD RELEASE THE LOOP AND WITHDRAW THE TUBE SHEATH FROM THE PATIENT USING A BIPOLAR SNARE ON THE FOLLOWING DAY. THE FACILITY STATED THAT THE LOOP BECAME STUCK IN THE TUBE SHEATH BECAUSE THE USER ADDED EXCESSIVE FORCE TO FASTEN THE LOOP WHILE USER TRIED TO PLACE THE LOOP OVER THE CLIPS. THE CLIPS WERE REPORTEDLY DEPLOYED AROUND THE POLYP. THE FACILITY ALSO REPORTED THE USER USED THE SUBJECT DEVICE BY MISTAKE. ONLY THE TUBE SHEATH OF THE SUBJECT DEVICE WAS RETURNED TO OMSC FOR EVAL. THE EVAL CONFIRMED THAT THE ONE END OF THE TUBE SHEATH WAS CUT AND THE OTHER END WAS BURNED. OMSC REVIEWED THE MFG RECORDS OF THE SUBJECT DEVICE AND CONFIRMED THAT THERE WAS NO IRREGULARITY. OMSC DECIDED THAT THE MISHANDLING BY USER CAUSED THE EVENT. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP (OMSC) WAS INFORMED THAT DURING A COLONOSCOPY FOR POLYPECTOMY, THE USER SUCCESSFULLY PLACED AND TIGHTENED THE LOOP OVER A POLYP USING THE SUBJECT DEVICE; HOWEVER THEY COULD NOT RELEASE THE LOOP FROM THE TUBE SHEATH OF THE SUBJECT DEVICE. IT WAS ALSO REPORTED THAT THE FACILITY ABANDONED THE PROCEDURE BECAUSE THE FACILITY DID NOT POSSESS A LOOP CUTTER TO RELEASE THE LOOP FROM THE TUBE SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265296 SINGLE USE LIGATING DEVICE LIGATING DEVICE (POLY LOOP) MND OLYMPUS MEDICAL SYSTEMS CORPORATION HX-400U-30 2XK

    Patients

    Seq Age Sex Outcome Treatment
    1