BEUDAMED
    FDA Adverse Event Other Summary report: N

    HARRIS UTERINE MANIPULATOR

    MDR report key: 3958703 · Received June 26, 2014

    Report

    Report Number
    1216677-2014-00008
    Event Type
    Other
    Date Received
    June 26, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 23, 2014
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    LKF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL INC. IS CURRENTLY INVESTIGATION THE STATED COMPLAINT. ONCE ALL AVAILABLE INFORMATION HAS BEEN RECEIVED AND THE INVESTIGATION COMPLETE, A FINAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED THAT DURING A DIAGNOSTIC LAPAROSCOPIC PROCEDURE FOR PERSISTENT PAIN, A 5CM DISTAL TIP OF A HUMI WAS DISCOVERED AND REMOVED. THIS PATIENT HAD UNDERGONE A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY ON (B)(6) 2010 WHICH IT HAS BEEN PRESUMED THAT DURING THAT PROCEDURE THE TIP HAD BROKEN AND WAS LEFT BEHIND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373429 HARRIS UTERINE MANIPULATOR HUMI LKF COOPERSURGICAL, INC. HUMI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention