BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCH KOH-EFFICIENT 4.0 CM ASSOCIATED HANDLE: ADVINCULA ARCH HANDLE

    MDR report key: 23757466 · Received December 8, 2025

    Report

    Report Number
    MW5180172
    Event Type
    Malfunction
    Date Received
    December 8, 2025
    Date of Event
    December 3, 2025
    Report Date
    December 3, 2025
    Manufacturer
    COOPER SURGICAL INC.
    Product Code
    HEW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DEVICE NAME: ARCH KOH-EFFICIENT 4.0 CM USED WITH ADVINCULA ARCH HANDLE, CLIP BROKE OFF DURING USE, NO PATIENT HARM OCCURRED. BROKEN PART RETRIEVED, REPLACEMENT OPENED AND USED. REFERENCE NUMBER: (B)(4). LOT NUMBER: 550019225; EXPIRATION DATE: 12-03-2027.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2877889 ARCH KOH-EFFICIENT 4.0 CM ASSOCIATED HANDLE: ADVINCULA ARCH HANDLE CULDOSCOPE (AND ACCESSORIES) HEW COOPER SURGICAL INC. KCS-ARCH-40 550019225

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female