BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELLE DE CORNIER MARK II

    MDR report key: 5117896 · Received September 11, 2015

    Report

    Report Number
    9612445-2015-00001
    Event Type
    Injury
    Date Received
    September 11, 2015
    Date of Event
    May 22, 2015
    Report Date
    August 11, 2015
    Manufacturer
    PRODIMED
    Product Code
    HHK
    PMA / PMN Number
    K881456
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    BY OBSERVING THE RETURNED BROKEN PIPELLE TIP, IT APPEARS THAT THE PIPELLE HAS BEEN BROKEN AT THE ROUGHENING PART. THIS MEDICAL DEVICE IS CURRENTLY ROUGHENED ON THE LAST 3 CM ON ITS' EXTREMITY. THE FIRST HYPOTHESIS IS THAT THE ROUGHENING PROCESS COULD HAVE WEAKENED THE MEDICAL DEVICE. SO WE CHECKED THE PROCESS OF ROUGHENING; THE PARAMETERS OF ROUGHENING MACHINE ARE ADJUSTED TO AVOID TO ROUGHEN TOO MUCH THE TIP OF THE MEDICAL DEVICE THAT COULD LEAD TO A TOO SMALL THICKNESS OF THE EXTREMITY OF THE DEVICE. THE PARAMETERS APPLIED ON THIS BATCH WERE CONFORMED TO THE SPECIFICATIONS. THE SECOND HYPOTHESIS IS AN ERROR OF AN OPERATOR. HOWEVER, WE CHECKED THE DHR AND FOUND NO DEVIATION IN THE PROCESS. FURTHERMORE, IT'S BEEN AT LEAST 4 YEARS SINCE WE'VE HAD THIS TYPE OF INCIDENT WITH (B)(4) UNITS SOLD SINCE 2012. THE MOST PROBABLE ROOT CAUSE IS AN ERROR DURING THE USE OF THE DEVICE: THE TUBE MAY BE WEAKENED BY A SHARP OBJECT BEFORE USE.

    Description of Event or Problem · 1

    PATIENT PRESENTED FOR ENDOMETRIAL BIOPSY FOR RESEARCH CLINICAL TRIAL THERAPEUTICS TXC (B)(6). WHEN THE PIPELLE WAS WITHDRAWN, 3.5CM OF THE OUTER SHEATH WAS MISSING AND WAS RETAINED IN THE ENDOMETRIAL CAVITY. THE PATIENT REQUIRED A HYSTEROSCOPY D&C UNDER GENERAL ANESTHESIA TO RETRIEVE THE SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603188 PIPELLE DE CORNIER MARK II NA HHK PRODIMED 1111200 6103/C909

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention