BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS ALLIGATOR JAW-STEP

    MDR report key: 2860305 · Received November 16, 2012

    Report

    Report Number
    8010047-2012-00433
    Event Type
    Other
    Date Received
    November 16, 2012
    Report Date
    October 22, 2012
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    KGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFORMATION. PER THE USER FACILITY, THIS HAS BEEN AN ONGOING PROBLEM OVER THE LAST MONTH. ALL THE PROCEDURES WERE DIAGNOSTIC COLONOSCOPIES WITH POLYPECTOMY. THE PHENOMENON OCCURRED WHEN THE USER WAS CAUTERIZING THE POLYP. THE AREA WOULD BLEED A LOT BUT NO INTERVENTION WAS PERFORMED TO STOP THE BLEEDING. ALL THE PROCEDURES WERE FINISHED WITH ANOTHER LOT OF FORCEPS. THE SITE USED A VALLEY LAB FORCE FX ELECTROSURGICAL GENERATOR (ESG). THE ESG WAS CHECKED BY BIOMED AND WAS FUNCTIONING APPROPRIATELY. NO DEVICE WAS RETURNED FOR EVALUATION. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT THE FORCEPS WOULD "BLANCH" THE TISSUE AND CAUSE EXCESSIVE BLEEDING. THE USER FACILITY STATED THAT THEY WENT THROUGH THREE BOXES BEFORE THEY CHANGED TO A DIFFERENT LOT NUMBER. PROCEDURE WAS COMPLETED WITH THE SAME TYPE OF FORCEPS BUT DIFFERENT LOT NUMBER. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS ALLIGATOR JAW-STEP DISPOSABLE HOT BIOPSY FORCEPS KGE OLYMPUS MEDICAL SYSTEMS CORPORATION FD-210U 25K

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other VALLEYLAB FORCE FX ELECTROSUGIRCAL UNIT| MODEL# / SN# UNKNOWN