BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO CLINCH* II 5MM INSTRUMENT

    MDR report key: 5310368 · Received December 18, 2015

    Report

    Report Number
    2647580-2015-00914
    Event Type
    Malfunction
    Date Received
    December 18, 2015
    Date of Event
    December 7, 2015
    Report Date
    January 11, 2016
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO INC
    Product Code
    HAD
    PMA / PMN Number
    K903205
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF TWO DEVICES OPENED BY THE ACCOUNT. THIS EVALUATION WAS BASED ON A TECHNICAL REVIEW OF ALL DATA RECEIVED FROM THE SITE, A PMV REVIEW OF MANUFACTURING RECORDS, AN ENGINEERING REVIEW, A PMV REVIEW OF COMPLAINT TRENDS, AND AN EVALUATION OF THE RETURNED DEVICE. THE DEVICES WERE RECEIVED WITH A BROKEN JAW. ENGINEERING OBSERVED THAT THE SHAFTS WERE BENT. ENGINEERING ALSO OBSERVED THAT THE TUBE HOUSING WAS BROKEN FOR DEVICE TWO. NO FUNCTIONAL TESTING COULD BE PERFORMED DUE TO THE DAMAGES. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THIS DEVICE LOT NUMBER WAS RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. ENGINEERING CONCLUDED THAT THE ROOT CAUSE FOR THE REPORTED DEFECT WAS THE USE OF EXCESSIVE MANIPULATION BY USER THAT CONSEQUENTLY CAUSED THE BREAKAGE OF THE TUBE HOUSING TABS. THE RECEIVED UNIT IS CONSISTENT WITH A UNIT THAT WAS MANIPULATED WITH EXCESSIVE FORCE DURING PROCEDURE BY USER, USING THE DEVICE AS A LEVER INCREASING THE STRESS FORCE ON THE TABS OF THE TUBE. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A LAP HYS. ACCORDING, THE SHAFT BENT AT THE TIP OF INSTRUMENT TO THE JAWS. JAW WENT LIMP. NOTHING FELL INTO THE PATIENT BUT A X-RAY WAS TAKEN ENSURE NO COMPONENT LEFT IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836254 ENDO CLINCH* II 5MM INSTRUMENT FORCEPS, OBSTETRICAL HAD COVIDIEN, FORMERLY USSC PUERTO RICO INC 174317 P5G0475X

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention