BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOLSEAL GENERATOR

    MDR report key: 13417863 · Received February 1, 2022

    Report

    Report Number
    3010377594-2022-00003
    Event Type
    Malfunction
    Date Received
    February 1, 2022
    Date of Event
    January 17, 2000
    Report Date
    February 1, 2022
    Manufacturer
    BOLDER SURGICAL
    Product Code
    GEI
    UDI-DI
    00850346007023
    PMA / PMN Number
    K202114
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BOLDER SURGICAL'S ITALIAN DISTRIBUTOR REPORTED A PATIENT LEAKAGE FAILURE WITH COOLSEALTM GENERATOR SERIAL NUMBER (B)(4) WHEN PERFORMING TESTING PER IEC 60601-1. THE COOLSEALTM GENERATOR WAS RETURNED TO BOLDER SURGICAL FOR INVESTIGATION AND THE COMPLAINT WAS CONFIRMED. IT WAS DETERMINED THAT AN ADDITIONAL STANDOFF WAS ADDED TO THE BASE ASSEMBLY DURING MANUFACTURING, WHICH LED TO A CONNECTION BETWEEN THE PATIENT ISOLATION BARRIER AND GROUND. AS A RESULT, THE 00165 DEVICE DID NOT MEET THE IEC 60601-1 PATIENT LEAKAGE REQUIREMENTS FOR THE DEVICE. THIS CONDITION REPRESENTS THE POTENTIAL TO DELIVER UNINTENDED ENERGY TO A PATIENT. RISK ASSESSMENT HAS DETERMINED THAT PATIENT INJURY IS VERY UNLIKELY.

    Description of Event or Problem · 0

    A DISTRIBUTOR REPORTED A PATIENT LEAKAGE FAILURE WITH COOLSEAL GENERATOR. IN THIS CASE THERE WAS NO PATIENT IMPACT AS THE ISSUE WAS DISCOVERED BEFORE THE GENERATOR WAS PUT INTO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1183691 COOLSEAL GENERATOR GENERATOR FOR ELECTROSURGICAL TISSUE SEALER GEI BOLDER SURGICAL CSL-200-50 NA 00850346007023

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown