BEUDAMED
    FDA Adverse Event Other Summary report: N

    DISPOSABLE ELECTROSURGICAL SNARE

    MDR report key: 3011160 · Received March 14, 2013

    Report

    Report Number
    8010047-2013-00054
    Event Type
    Other
    Date Received
    March 14, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 13, 2013
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    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 ADD'L INFO REGARDING THIS REPORT. THE USER REPORTED THAT THEY USED NON-OLYMPUS ELECTRO SURGICAL UNIT AND THE UNIT HAD BEEN SET FOR AUTOCUT 120W AND SOFT COAG 60W, AND THERE MIGHT BE SOMETHING IRREGULAR IN THE ELECTRO SURGICAL UNIT. THE SUBJECT DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OMSC FOR EVAL. THE EVAL CONFIRMED THAT THERE WERE SOME BURNED FOREIGN MATERIAL ON THE SNARE. THERE WERE NO OTHER ABNORMALITIES RELATED TO THE PHENOMENON IN THE SUBJECT DEVICE AND ITS 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 SYSTEM CORP (OMSC) WAS INFORMED THAT DURING A COLONOSCOPY POLYPECTOMY USING THE SUBJECT DEVICE, A PHYSICIAN EXPERIENCED DIFFICULTY REMOVING THE SNARE OF THE SUBJECT DEVICE FROM A POLYP ABOUT 2CM IN SEIZE. IT WAS REPORTED THAT THE PHYSICIAN EVENTUALLY COULD REMOVE THE SNARE FROM THE POLYP AFTER HE OPERATED THE HANDLE OF THE DEVICE FOR SEVERAL MINUTES. THE FACILITY REPORTEDLY COMPLETED THE PROCEDURE USING ANOTHER SNARE. THERE WAS NO REPORT OF PT INJURY REGARDING THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108297 DISPOSABLE ELECTROSURGICAL SNARE ELECTROSURGICAL SNARE GEI OLYMPUS MEDICAL SYSTEMS CORP. SD-210U-15 2ZK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK