BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HTA HYSTEROSCOPE ADAPTER, STORZ

    MDR report key: 19050595 · Received April 5, 2024

    Report

    Report Number
    3011011193-2024-00006
    Event Type
    Injury
    Date Received
    April 5, 2024
    Date of Event
    January 18, 2024
    Report Date
    April 5, 2024
    Manufacturer
    MINERVA SURGICAL INC
    Product Code
    NWW
    UDI-DI
    08714729469773
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MINERVA SURGICAL HAS ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION FROM THE FACILITY WITH LIMITED SUCCESS. BASED ON THE AVAILABLE INFORMATION, IT HAS BEEN DETERMINED THAT THE POTENTIAL CAUSE OF THE EVENT WAS DUE TO THE MALFUNCTION OF AN HTA ADAPTER, A GENESYS HTA ACCESSORY, THAT HAS BEEN IN USE AT THE FACILITY SINCE 2005. THE ADAPTER HAS BEEN USED WELL PAST ITS INTENDED LIFE AND RECOMMENDED REPROCESSING CYCLES. IT IS SUSPECTED THE WEAR AND DEGRADATION OF THE 2005 ADAPTER CAUSED LEAKING WHICH ULTIMATELY LED TO THE REPORTED BURN. THE HTA ADAPTER USED IN THIS CASE WAS NOT RETURNED AND THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED. DUE TO THE AGE OF THE DEVICE (CIRCA 2005), THE LOT NUMBER BEING UNKNOWN, AND THE DEVICE NOT MANUFACTURED BY MINERVA SURGICAL; A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. A RISK REVIEW WAS PERFORMED. THE RISK OF A MINOR BURN IS ASSOCIATED WITH A LEAKING ADAPTER CAUSED BY MATERIAL DEGRADATION. THE GENESYS HTA SYSTEM'S USER MANUAL PROVIDES GUIDANCE AND STEPS FOR PROPER CLEANING AND STERILIZATION AND STATES THE ADAPTER MAY BE REUSED/RESTERILIZED UP TO 40 TIMES. THE MINERVA SURGICAL REPRESENTATIVE WAS NOT PRESENT FOR THE CASE BUT FOLLOWED UP WITH THE FACILITY AND PERFORMED AN IN-SERVICE AND PRODUCT EDUCATION ON JANUARY 19TH, 2024. MINERVA SURGICAL WAS NOT MADE AWARE OF ANY MEDICAL INTERVENTION. IT WAS REPORTED THE FACILITY DISCARDED ALL ADAPTERS FROM 2005 AND IT HAS BEEN CONFIRMED THE FACILITY ORDERED REPLACEMENTS.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC COMPLAINT DEPARTMENT FORWARDED A MEDWATCH REPORT, 2302300000-2024-8002, TO THE MINERVA SURGICAL COMPLAINT DEPARTMENT ON MARCH 21ST, 2024. THE MEDWATCH REPORT STATED "PATIENT PRESENTED TO THE OPERATING ROOM (OR) FOR A PLANNED DILATION AND CURETTAGE (D&C), HYDROTHERMAL ABLATION (HTA) PROCEDURE. DURING THE SURGERY, THE HTA EQUIPMENT FAILED, ALLOWING THE SCOPE TO BECOME INCREDIBLY HOT AND BURNED THIS PATIENT'S VAGINAL OPENING AND CERVIX. WE LEARNED THAT THE WOLF HYSTEROSCOPE ADAPTER WAS SUPPOSED TO BE REPLACED AT EVERY 40 USES WHICH WE DID NOT DO. WE HAVE DISCARDED ALL OF OUR SUPPLIES FROM 2005 AND HAVE ORDERED ALL NEW ONES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76298 HTA HYSTEROSCOPE ADAPTER, STORZ HYSTEROSCOPE ADAPTER NWW MINERVA SURGICAL INC UNKNOWN 08714729469773

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other