BEUDAMED
    FDA Adverse Event Other Summary report: N

    HUMI-HARRIS UTERINE MANI

    MDR report key: 4955939 · Received July 29, 2015

    Report

    Report Number
    1216677-2015-00042
    Event Type
    Other
    Date Received
    July 29, 2015
    Date of Event
    June 15, 2015
    Report Date
    July 20, 2015
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    LKF
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CONCERNING THE REPORTED EVENT CANNOT BE VERIFIED AS THE AFFECTED SAMPLE WILL NOT BE RETURNED FOR INVESTIGATIVE ANALYSIS. HOWEVER, IF IN THE FUTURE THE SAMPLE IS RETURNED, THIS COMPLAINT INVESTIGATION MAYBE REOPENED FOR CONTINUED INVESTIGATIVE ANALYSIS. THE HUMI-HARRIS UTERINE MANIPULATOR, PRODUCT NUMBER 6001 IS MANUFACTURED BY AN OUTSIDE VENDOR AS AN OEM PRODUCT FOR COOPER SURGICAL. THE VENDOR WAS CONTACTED AND MADE AWARE OF THE REPORTED COMPLAINT AND VERIFIED THAT THEIR PROCESS WAS UNCHANGED AND CLAIMED THAT THEY WERE ASSURED THAT THEIR PROCESS COULD NOT PRODUCE A CONDITION AS THE ONE REPORTED. A LOT DHR REVIEW WAS PERFORMED AND DID NOT REVEAL ANY ABNORMALITY. THE TYPE OF REPORTED COMPLAINT WILL BE MONITORED FOR TRENDING, PREVIOUSLY REPORTED COMPLAINTS THAT REPORTED A BROKEN OR DAMAGED DEVICE INDICATED THAT THE MOST LIKELY ROOT CAUSE COULD BE ATTRIBUTED TO IMPROPER MANNER OF USE.

    Description of Event or Problem · 1

    "HARRIS-KRONNER UTERINE MANIPULATOR LOT: 047045; EXPIRY: 2016 07. INSERTED AND BALLOON INFLATED AS PER MANUFACTORY DIRECTION. WHEN BEING USED APPROPRIATELY, THE PORTION INSERTED INTO THE UTERINE CAVITY SNAPPED AT THE SPRING JOIN. THE FAULT WAS IMMEDIATELY IDENTIFIED AND THE FRAGMENT WAS RETRIEVED WITH THE SCRUB NURSE, SURGEON AND ASSISTANT WERE CONFIDENT ALL PIECES WERE RETRIEVED." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494726 HUMI-HARRIS UTERINE MANI HUMI LKF COOPERSURGICAL, INC. 6001 147045

    Patients

    Seq Age Sex Outcome Treatment
    1