BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEEP PRECISION GENERATOR

    MDR report key: 9590719 · Received January 15, 2020

    Report

    Report Number
    1216677-2019-00328
    Event Type
    Malfunction
    Date Received
    January 15, 2020
    Date of Event
    November 19, 2019
    Report Date
    January 15, 2020
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    PMA / PMN Number
    K963653
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 4/12/17 UNDER WO #(B)(4) AND SHIPPED ON 4/12/17. MANUFACTURING RECORD REVIEW: DHR'S (B)(4) 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: THIS UNIT WAS RETURNED TO CSI FOR RF LEAKAGE THAT WAS NOT CONFIRMED ON LOG 92942 ON 9/26/2019. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY REVEALS ONE SIMILAR REPORTED COMPLAINT CONDITION. NOT CONFIRMED. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED ON REPAIR LOG 93440. 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. *CORRECTION AND/OR CORRECTIVE ACTION: THE UNIT WAS FITTED WITH A NEW BOARD, TESTED TO SPECIFICATIONS, AND RETURNED TO THE CUSTOMER. ENGINEERING INPUT ON THE PROBLEM DESCRIPTION SUGGESTED THERE MAY BE A SET UP ISSUE BY THE END USER. A FOLLOW UP WITH THE CUSTOMER WAS SUGGESTED TO CONFIRM THE RETURNED UNIT IS WORKING FREE OF RF LEAKAGE ERRORS. NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. NO FURTHER TRAINING REQUIRED AT THIS TIME. *PREVENTATIVE ACTION ACTIVITY: COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR ANY TRENDS.

    Description of Event or Problem · 0

    CUSTOMER STATED "PER RAY - MUST FIND RF LEAKAGE". REFERENCE REPAIR ORDER (B)(4). REF: (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

    CUSTOMER STATED "PER RAY - MUST FIND RF LEAKAGE". REFERENCE REPAIR ORDER #: (B)(4). REF: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57417 LEEP PRECISION GENERATOR LEEP PRECISION HGI COOPERSURGICAL, INC. LP-20-120 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other