BEUDAMED
    FDA Adverse Event Other Summary report: N

    ELECTROSURGICAL SNARE

    MDR report key: 3031937 · Received March 26, 2013

    Report

    Report Number
    8010047-2013-00058
    Event Type
    Other
    Date Received
    March 26, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OMSC FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS REPORT. THE USER REPORTED THAT THEY FAILED TO CONFIRM THE CLIP BEHIND THE POLYP WHEN THEY POSITIONED THE SNARE AROUND THE POLYP. IT WAS REPORTED THAT THE SNARE WIRE WAS EXCRETED FROM THE PATIENT 6 DAYS AFTER THE PROCEDURE AND THERE WAS NO INJURY. THE SUBJECT DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OMSC FOR EVALUATION. HOWEVER, THERE WERE NO ABNORMALITIES RELATED TO THE PHENOMENON IN IT'S PRODUCT RECORD. 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 POLYPECTOMY USING THE SUBJECT DEVICE, THE USER COULD NOT WITHDRAW THE SUBJECT DEVICE FROM THE PATIENT SINCE THE DISTAL END OF THE SNARE WIRE ADHERED TO THE PLASTIC PORTION OF A CLIP. THE PHYSICIAN REPORTEDLY DECIDED TO LEAVE THE SNARE WIRE OF THE SUBJECT DEVICE IN THE PATIENT AND WAIT IT'S NATURAL EXCRETION. IT WAS REPORTED THAT THE FACILITY COMPLETED THE PROCEDURE AFTER THEY CUT THE SNARE WIRE OF THE SUBJECT DEVICE. THE PATIENT WAS REPORTEDLY DISCHARGED FROM THE HOSPITAL SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123954 ELECTROSURGICAL SNARE ELECTROSURGICAL SNARE GEI OLYMPUS MEDICAL SYSTEMS CORPORATION SD-6U-1 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR