BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IRIS SCISSOR(#130-S), HEMOSTAT MOSQUITO(#161)

    MDR report key: 2534513 · Received March 22, 2012

    Report

    Report Number
    1125236-2012-00001
    Event Type
    Injury
    Date Received
    March 22, 2012
    Date of Event
    March 5, 2012
    Report Date
    March 22, 2012
    Manufacturer
    MARYAM TRADING
    Product Code
    LRW
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L MODEL # 161. ADD'L LOT #: G ((B)(4)).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE SCISSOR AND HEMOSTAT INSTRUMENTS DID NOT FUNCTION PROPERLY DURING A NEONATAL PROCEDURE. THE SCISSORS WOULD NOT CUT AND THE HEMOSTAT BROKE. NEONATOLOGIST STATED THERE WAS A TWO MIN DELAY IN THE PROCEDURE WHICH DID NOT AFFECT OR INJURE THE PT IN ANY MEASURABLE WAY AND NO SPECIAL MEASURES WERE TAKEN. RN STATES THERE WAS A DELAY IN PROCEDURE AND THE BABY HAD LOW BLOOD SUGAR PARTIALLY AS A RESULT OF THE DELAY. NO RESIDUAL EFFECTS ARE REPORTED OR ANTICIPATED. REC'D THE SAMPLES AND CHECKED ONE BY ONE THOROUGHLY BY OUR (IMPORTER) QUALITY ASSURANCE TEAM FROM EVERY ANGLE AND FOUND EVERY INSTRUMENTS IN THAT TRAY WORKS AN EXCELLENT AND PROPERLY MANNER EXCEPT ONE WHICH IS BROKEN. THE MATTER OF FACT IS THAT SCISSORS AND FORCEPS DOES NOT BELONG TO ONE MFR. FOR GENERAL INFO, CRACK PORTION OF MAIL PART OF MOSQUITO HEMOSTAT ALWAYS INVISIBLE TO QUALITY INSPECTOR AND THEREFORE SOMETIME 1 IN MILLION FORCEPS CAN REMAIN CRACK DUE TO NON VISIBLE PORTION. SO SURGICAL DESIGN'S ONE STEP UP QUALITY LINE "FG" CODES IS THE BEST FOR THIS KIND OF PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IRIS SCISSOR(#130-S), HEMOSTAT MOSQUITO(#161) SCISSOR, HEMOSTAT LRW MARYAM TRADING 130-S MT (MARYAM)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention