BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE BOX OF 10

    MDR report key: 8336650 · Received February 13, 2019

    Report

    Report Number
    1216677-2019-00031
    Event Type
    Malfunction
    Date Received
    February 13, 2019
    Date of Event
    January 27, 2019
    Report Date
    December 8, 2019
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HAM
    PMA / PMN Number
    K884174
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    REF (B)(4). INVESTIGATION: NO SAMPLE RETURNED, REVIEW DHR. ANALYSIS AND FINDINGS: IT HAS BEEN APPROXIMATELY 65 DAYS AND THE REPORTED SAMPLE HAS NOT BEEN RETURNED FOR INVESTIGATIVE ANALYSIS. THE HANDPIECE IS PURCHASED FROM AND POUCHED BY A SUPPLIER. THE INDIVIDUAL POUCHES ARE PLACED INTO PACKAGING AT COOPERSURGICAL. A REVIEW OF TWO YEAR COMPLAINT HISTORY SHOWS NO COMPLAINTS FOR THIS ISSUE. A REVIEW OF THE DHR (171329) DID NOT SHOW ANY ABNORMALITIES. THE PRODUCT WAS PACKAGED AT COOPERSURGICAL IN FEBRUARY 2016. LOT 037886 HAS BEEN DEPLETED FROM FINISHED GOODS INVENTORY. THE REPORTED COMPLAINT COULD NOT BE VERIFIED OR CONFIRMED DUE TO THE AFFECTED SAMPLE NOT BEING RETURNED FOR INVESTIGATIVE ANALYSIS. BASED ON THE INFORMATION FROM ABOVE, THE REPORTED COMPLAINT IS CONSIDERED AN ISOLATED INCIDENT. CORRECTION AND/OR CORRECTIVE ACTION: NONE. REASON: NO FURTHER ACTION IS NEEDED AT THIS TIME. HOWEVER, THIS COMPLAINT WILL BE REOPENED AND RE-EVALUATED SHOULD THE SAMPLES BE RETURNED. WAS THE COMPLAINT CONFIRMED? NO. PREVENTATIVE ACTION ACTIVITY: COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR ANY TRENDS.

    Description of Event or Problem · 0

    "THE CAUTERY FAILED DURING LEEP PROCEDURE." REF (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE FILED. REF E-COMPLAINT-(B)(4).

    Description of Event or Problem · 1

    "THE CAUTERY FAILED DURING LEEP PROCEDURE." REF E-COMPLAINT-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127279 HANDPIECE BOX OF 10 HANDPIECE BOX OF 10 HAM COOPERSURGICAL, INC. 6040 037886

    Patients

    Seq Age Sex Outcome Treatment
    1 Other