BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEEP PRECISION GENERATOR

    MDR report key: 9771184 · Received February 28, 2020

    Report

    Report Number
    1216677-2020-00070
    Event Type
    Malfunction
    Date Received
    February 28, 2020
    Date of Event
    January 31, 2020
    Report Date
    May 25, 2020
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    PMA / PMN Number
    K963653
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    *INVESTIGATION X-REVIEW DHR X-INSPECT RETURNED SAMPLES *ANALYSIS AND FINDINGS COMPLAINT #(B)(4). DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 6/21/17 UNDER WO #222988 & 224638 AND SHIPPED ON 7/20/17. MANUFACTURING RECORD REVIEW: DHR'S 222988 & 224638 WERE REVIEWED AND NON-CONFORMITIES, UNRELATED TO THE COMPLAINT CONDITION, WERE NOTED. NONE OF THE OBSERVED NOTES INDICATE A SIMILAR ISSUE. INCOMING INSPECTION REVIEW: NOT APPLICABLE. SERVICE HISTORY RECORD: NO ADDITIONAL SERVICE HISTORY RECORDS FOUND FOR THIS UNIT. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED NO SIMILAR REPORTED COMPLAINT CONDITIONS. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED ON REPAIR. HOWEVER, BASED ON LOG #93822 THIS UNIT AS AT CSI ON 2/5/220. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT UNIT REVEALED NO PHYSICAL DAMAGE. FUNCTIONAL EVALUATION: COMPLAINT UNIT WAS FUNCTIONALLY EVALUATED AND FOUND TO FUNCTION PROPERLY. ROOT CAUSE : THE PRODUCT TESTED TO SPECIFICATION AS THE DEVICE WAS FOUND TO MEET ALL VISUAL AND FUNCTIONAL TEST SPECIFICATIONS. ROOT CAUSE NOT APPLICABLE AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. THE PROBLEM IS SUSPECTED TO RESIDE WITH THE END USER. IT IS POSSIBLE THE UNIT WAS NOT FULLY INSERTED INTO THE CART. FULL INSERTION IS REQUIRED TO MAKE CONTACT WITH PLUG INSIDE. *CORRECTION AND/OR CORRECTIVE ACTION THE UNIT WAS EVALUATED AND TESTED SUCCESSFULLY TO SPECIFICATIONS. UPON COMPLETION, THE UNIT WAS RETURNED TO THE CUSTOMER. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. *PREVENTATIVE ACTION ACTIVITY COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS.

    Description of Event or Problem · 0

    SMOKE EVACUATOR NOT WORKING WITHOUT PURGING EVERY USE UNABLE TO USE HAND PIECE WITHOUT BUTTON CAN ONLY USE HAND PIECE WITH FOOT PEDAL. ORDER: 93822 REF:E-COMPLAINT-(B)(4)

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CONDITION REPORTED IS CURRENTLY BEING INVESTIGATED BY COOPERSURGICAL, INC. REFERENCE : (B)(4).

    Description of Event or Problem · 1

    SMOKE EVACUATOR NOT WORKING WITHOUT PURGING EVERY USE UNABLE TO USE HAND PIECE WITHOUT BUTTON CAN ONLY USE HAND PIECE WITH FOOT PEDAL. ORDER: (B)(4). REF: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235569 LEEP PRECISION GENERATOR LEEP PRECISION HGI COOPERSURGICAL, INC. LP-20-120 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other