BEUDAMED
    FDA Adverse Event Other Summary report: N

    DISPOSABLE MINI ENDOCUT SCISSORS TIP

    MDR report key: 1943827 · Received December 23, 2010

    Report

    Report Number
    1223422-2010-00008
    Event Type
    Other
    Date Received
    December 23, 2010
    Date of Event
    October 6, 2010
    Report Date
    December 22, 2010
    Manufacturer
    MICROLINE SURGICAL INC
    Product Code
    KNS
    PMA / PMN Number
    K962119
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ONE TIP WAS RECEIVED DECONTAMINATED AND INVESTIGATED. THE TIP WAS RETURNED WITH THE HEAT SHRINK TUBING SEPARATED FROM THE TIP. A PHOTO WAS ALSO RECEIVED SHOWING THE HEAT SHRINK TUBING NEXT TO THE JAWS OF THE TIP, WHICH WAS RETRIEVED FROM THE PT. RECEIVED ONLY ONE TIP FOR THIS COMPLAINT, LOT # 00102041. THE SECOND TIP IN QUESTION OR STERILE TIPS FOR LOT NUMBER 00102923 WAS NOT RETURNED. THE RETURNED TIP HAD THE HEAT SHRINK TUBING REMOVED AND WAS HEAVILY DEFORMED AND DAMAGED; THEREFORE, AN ELECTRICAL TEST COULD NOT BE PERFORMED DUE TO THIS DAMAGE. THE RETURNED TIP WAS EVALUATED MECHANICALLY AND FOUND TO PASS ALL THE SPECIFICATIONS REGARDING THREAD GAGE, CUT TEST AND FORCE REQUIRED TO COMPLETELY CLOSE THE SCISSOR TIP. THERE WAS NOT ENOUGH INFO TO DETERMINE THE ROOT CAUSE. NO ISSUES WERE FOUND WITH EITHER DEVICE HISTORY RECORDS.

    Description of Event or Problem · 1

    PT SUFFERED TWO MINOR BURNS TO UTERUS WALL VIA THE SCISSORS TIP. THE INSULATION APPEARED TO BE FAULTY AND THE TIP WAS REMOVED FROM SERVICE. NO ADDITIONAL PT INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE MINI ENDOCUT SCISSORS TIP MINI ENDOCUT SCISSORS TIP KNS MICROLINE SURGICAL INC 3152 00102041

    Patients

    Seq Age Sex Outcome Treatment
    1