BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELLE DE CORNIER MARK II

    MDR report key: 5007300 · Received August 13, 2015

    Report

    Report Number
    1833117-2015-00005
    Event Type
    Injury
    Date Received
    August 13, 2015
    Date of Event
    May 22, 2015
    Report Date
    August 11, 2015
    Manufacturer
    LABORATORIES PRODIMED, ZI
    Product Code
    HHK
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    1

    Narratives

    Description of Event or Problem · 1

    PATIENT PRESENTED FOR ENDOMETRIAL BIOPSY FOR RESEARCH CLINICAL TRIAL THERAPEUTICS TXC12-05. WHEN THE PIPELLE WAS WITHDRAWN, 3.5 CM OF THE OUTER SHEATH WAS MISSING AND WAS RETAINED IN THE ENDOMETRIAL CAVITY. THE PATIENT REQUIRED A HYSTEROSCOPY D AND C UNDER GENERAL ANESTHESIA TO RETRIEVE THE SHEATH. COMMUNICATION FROM DR. (B)(6). FROM: (B)(6), SENT: TUESDAY, JULY 14, 2015 3:05 PM. TO: (B)(4). SUBJECT: ADVERSE EVENT WITH PIPELLE MARK II. I WANT TO INFORM YOU OF A PRODUCT FAILURE THAT REQUIRED A SURGICAL PROCEDURE TO REMEDY. IT IS THE PIPELLE MARK II DR. (B)(6), LOT # 6103 C909 EXP 04/2017. IT WAS USED TO AN ENDOMETRIAL BIOPSY. THE PROCEDURE WAS DONE IN THE USUAL FASHION, AND WAS NOT DIFFICULT. WHEN THE BIOPSY INSTRUMENT WAS REMOVED APPROXIMATELY 3.5 CM OF THE OUTER SHEATH WAS MISSING AND WAS STILL INSIDE THE UTERUS. I WAS UNABLE TO REMOVE IT IN THE OFFICE AND IT REQUIRED A HYSTEROSCOPY D AND C TO REMOVE THE RETAINED FOREIGN BODY. I AND THE PATIENT WANT TO KNOW IF THIS HAS HAPPENED PREVIOUSLY. THANK YOU. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535842 PIPELLE DE CORNIER MARK II ENDOMETRIAL SAMPLER HHK LABORATORIES PRODIMED, ZI 1111200 6103/C909

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention