BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEEP PRECISION GENERATOR

    MDR report key: 9834439 · Received March 16, 2020

    Report

    Report Number
    1216677-2020-00082
    Event Type
    Malfunction
    Date Received
    March 16, 2020
    Date of Event
    February 28, 2020
    Report Date
    June 3, 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 1/24/2019 UNDER WO #'S (B)(4) AND SHIPPED ON 2/1/2019. MANUFACTURING RECORD REVIEW: DHR'S 224637 & 222987 WERE REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW: NOT APPLICABLE. SERVICE HISTORY RECORD: NO ADDITIONAL SERVICE HISTORY RECORDS FOUND FOR THIS UNIT. HISTORICAL COMPLAINT REVIEW: A REVIEW OF 2-YEAR COMPLAINT HISTORY SHOWED SIMILAR REPORTED COMPLAINT CONDITIONS. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED ON A REPAIR. HOWEVER, BASED ON LOG 93995, THIS UNIT WAS AT CSI ON 3/4/2020. 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. IT IS SUSPECTED THE GENERATOR WAS NOT FULLY INSERTED INTO THE CART WHEN IN USE BY THE CUSTOMER. THIS CAN RESULT IN THE POWER INLET NOT FULLY ENGAGING. *CORRECTION AND/OR CORRECTIVE ACTION THE UNIT WAS TESTED TO SPECIFICATIONS AND 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

    CUSTOMER STATED "NOT CUTTING AND TURNS OFF". REFERENCE REPAIR ORDER #(B)(4). REF: (B)(4).

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CONDITION REPORTED IS CURRENTLY BEING INVESTIGATED BY COOPERSURGICAL, INC.

    Description of Event or Problem · 1

    CUSTOMER STATED "NOT CUTTING AND TURNS OFF". REFERENCE REPAIR ORDER #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301631 LEEP PRECISION GENERATOR LEEP PRECISION HGI COOPERSURGICAL, INC. LP-20-120 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other