BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCH KOH-EFFICIENT

    MDR report key: 21410318 · Received February 19, 2025

    Report

    Report Number
    1216677-2025-00010
    Event Type
    Malfunction
    Date Received
    February 19, 2025
    Report Date
    March 17, 2025
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HEW
    PMA / PMN Number
    K954311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED. 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 SHOW SIMILAR COMPLAINT CONDITIONS, HOWEVER THESE WERE NOT CONFIRMED. PRODUCT RECEIPT THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. VISUAL 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 EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. ROOT CAUSE: NO DEFINITIVE ROOT CAUSE FOR THIS ISSUE COULD BE RELIABLY DETERMINED AT THIS TIME, SINCE THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION NOR VERIFICATION. WITH THE INFORMATION PROVIDED, A ROOT CAUSE ANALYSIS CANNOT BE DEFINITIVELY PERFORMED. AS A WAY OF IMPROVING THE MANUFACTURING PROCESS, CSI STAFFORD HAS IMPLEMENTED 100% IN PROCESS INSPECTION OF THE PRODUCT VIA BEND TESTING AND PULL TESTING, FOLLOWED BY AN AQL QC INSPECTION REQUIRING THE THAT THE UNITS ALSO PASS A BEND AND PULL TEST. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTIONS REQUIRED AS THE COMPLAINT WAS NOT CONFIRMED.

    Additional Manufacturer Narrative · 0

    B3: 2004 DEVICE LOCATION IS UNKNOWN. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING A ROBOTIC HYSTERECTOMY IN 2024, WHEN THE CUP FROM AN ARCH KOH-EFFICIENT DETACHED INSIDE THE CERVIX. NO PATIENT HARM WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. UNKNOWN KOH EFFICIENT 2025-02-0000046.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41361 ARCH KOH-EFFICIENT COLPOTOMY TUBE HEW COOPERSURGICAL, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female