BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEEP PRECISION

    MDR report key: 16973030 · Received May 22, 2023

    Report

    Report Number
    1216677-2023-00082
    Event Type
    Malfunction
    Date Received
    May 22, 2023
    Date of Event
    May 3, 2023
    Report Date
    July 11, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    UDI-DI
    00888937014228
    PMA / PMN Number
    K963348
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COOPERSURGICAL, INC. IS INVESTIGATING THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 0

    DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 06/23/2015. MANUFACTURING RECORD REVIEW: DHR 177428 WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. THE SYSTEM DHR WAS NOT AVAILABLE. HOWEVER, EACH LOT IS THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL COOPERSURGICAL QUALITY RELEASE SPECIFICATIONS. SHOULD THE DEVICE HISTORY RECORD BE LOCATED GOING FORWARD, IT WILL BE REVIEWED, AND THIS COMPLAINT AMENDED ACCORDINGLY. INCOMING INSPECTION REVIEW: NOT APPLICABLE. SERVICE HISTORY RECORD: THIS UNIT WAS SERVICED FOR AN UNCONFIRMED COMPLAINT FOR LOW POWER IN 2019. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED NO SIMILAR REPORTED COMPLAINT CONDITION. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED ON A REPAIR. HOWEVER, BASED ON LOG (B)(4), THIS UNIT WAS AT CSI ON 6/19/2023. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT UNIT REVEALED NO PHYSICAL DAMAGE. FUNCTIONAL EVALUATION: THE UNIT FUNCTIONED FREE OF DEFECTS. THE UNIT WAS RETURNED WITH A NON-COOPER NAME BRAND ELECTRODE WITHOUT THE CORRECT END TO CONNECT TO THE LEEP PRECISION DEVICE. THE INCLUSION OF THE ELECTRODE INDICATES THE CUSTOMER HAD USED THIS ELECTRODE AND DETERMINED TO BE RELATED TO THE CUSTOMER'S COMPLAINT DESCRIPTION. ACCESSORY ITEMS TO BE USED WITH THE LEEP PRECISION ARE NOTED IN THE IFU AS COOPERSURGICAL APPROVED. AS SUCH, THE COMPLAINT CONDITION NOTED IS BEING ATTRIBUTED TO END USER ERROR. NOTE: THE UNIT RF LEAKAGE WAS ADJUSTED TO SPECIFICATION BUT NOT INDICATIVE OF A CORRESPONDING CAUSE TO THE COMPLAINT. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS.

    Description of Event or Problem · 0

    AS PER THE DETAILS RECEIVED ON INCOMING E-COMPLAINT (B)(4): "WE HAVE A MEDICAL INCIDENT WHERE BOTH THE DOCTOR AND PATIENT WERE SHOCKED DURING A PROCEDURE.".

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506753 LEEP PRECISION LEEP PRECISION HGI COOPERSURGICAL, INC. LP-10-120 N/A 00888937014228

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other