BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVINCULA DELINEATOR UTERINE MANIPULATOR WITH 3.5 CM ULTEM KOH-EFFICIENT

    MDR report key: 23522118 · Received November 11, 2025

    Report

    Report Number
    1216677-2025-00048
    Event Type
    Injury
    Date Received
    November 11, 2025
    Date of Event
    October 14, 2025
    Report Date
    January 5, 2026
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HEW
    UDI-DI
    00888937012750
    PMA / PMN Number
    K143650
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE LOCATION IS UNKNOWN. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    UPDATED: B4, G3, G6, H2, H3, H6, H11. DISTRIBUTION HISTORY A DISTRIBUTION HISTORY RECORD REVIEW WAS NOT POSSIBLE FOR THIS PRODUCT AS THE LOT NUMBER WAS NOT PROVIDED FOR INVESTIGATION MANUFACTURING RECORD REVIEW: A DHR REVIEW WAS NOT POSSIBLE AS A LOT NUMBER WAS NOT PROVIDED. HISTORICAL COMPLAINT REVIEW A REVIEW OF THE 2-YEAR COMPLAINT HISTORY DID NOT SHOW SIMILAR REPORTED COMPLAINT CONDITIONS WHERE LACERATION WAS INVOLVED WITH THIS PRODUCT. PRODUCT RECEIPT THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. VISUAL EVAL. EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. IF THE PRODUCT SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDED TO THIS INVESTIGATION. FUNCTIONAL EVAL. EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. ANY RELEVANT CUSTOMER OR CLINICAL INFORMATION THERE WAS NO RELEVANT CUSTOMER OR CLINICAL INFORMATION PROVIDED. ROOT CAUSE NO DEFINITIVE ROOT CAUSE FOR THIS ISSUE COULD BE RELIABLY DETERMINED AT THIS TIME, AS THE PRODUCT WAS NOT RETURNED FOR EVALUATION, NOR INFORMATION SUCH AS THE LOT NUMBER WAS PROVIDED

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A ROBOTIC ASSISTED LAPAROSCOPIC HYSTERECTOMY, THE PATIENT EXPERIENCED A VAGINAL LACERATION. IN ADDITION TO THE DELINEATOR, THE ALLY II UPS WAS BEING UTILIZED DURING THE PROCEDURE. LACERATION WAS SUTURED, VAGINAL PACKING WAS PLACED AND THE PATIENT WAS STABLE. AD750-KE35 KOH-EFF 2025-10-0000457.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567796 ADVINCULA DELINEATOR UTERINE MANIPULATOR WITH 3.5 CM ULTEM KOH-EFFICIENT UTERINE MANIPULATOR HEW COOPERSURGICAL, INC. AD750-KE35 UNKNOWN 00888937012750

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention