BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEEP SYSTEM 1000 ESU GEN.

    MDR report key: 15358815 · Received September 5, 2022

    Report

    Report Number
    1216677-2022-00253
    Event Type
    Malfunction
    Date Received
    September 5, 2022
    Date of Event
    August 22, 2022
    Report Date
    December 9, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    PMA / PMN Number
    K952483DISC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 0

    INVESTIGATION X-REVIEW DHR X-INSPECT RETURNED SAMPLES *ANALYSIS AND FINDINGS COMPLAINT 2022-08-0000483 DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 03/22/2013 UNDER WO #138803 AND SHIPPED ON 04/15/2013. MANUFACTURING RECORD REVIEW: DHR 138803 WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW: NOT APPLICABLE. SERVICE HISTORY RECORD: THIS UNIT WAS SERVICED UNDER LOG 98031 FOR A BLOWN FUSE, F2 AND WAS UPDATED WITH A NEW DIAPHRAGM 4/5/2022. THIS UNIT WAS KEPT IN SERVICE & REPAIR FOR OBSERVATION OF F2. ITS'S DIRECT REPLACEMENT WAS NOT BLOWN IN THE WEEK IT WAS LEFT ON FOR OBSERVATION AND SUBSEQUENTLY RETURNED. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED SIMILAR REPORTED COMPLAINT CONDITION. SIMILAR COMPLAINTS MADE REFERENCE TO AN "ERROR 2" MESSAGE PREVIOUSLY ADDRESSES WITH UPDATED CAPACITORS ON C16 AND C17. THE LOSS OF POWER IS THE FAILURE MODE SIMILAR TO THIS COMPLAINT, BUT THIS COMPLAINT DOES NOT NOTE AN ERROR CODE. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED ON A REPAIR. HOWEVER, BASED ON LOG 99014, THIS UNIT WAS AT CSI ON 8/24/2022. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT UNIT REVEALED NO PHYSICAL DAMAGE. FUNCTIONAL EVALUATION: COMPLAINT UNIT WAS FUNCTIONALLY EVALUATED AND FOUND TO NOT FUNCTION PROPERLY. SERVICE & REPAIR NOTED F2 WAS BLOWN. ROOT CAUSE: IT IS POSSIBLE THE UNIT WAS IN A UNIQUE SETTING WHEN IN USE BY THE END USER. A DEFINITIVE ROOT CAUSE CANNOT BE RELIABLY DETERMINABLE AT THIS TIME. *CORRECTION AND/OR CORRECTIVE ACTION THE UNIT WAS UPDATED WITH ALL REPLACEABLE COMPONENTS, D3, C18, C14, AND C20 IN ADDITION TO THE FUSE ON F2. THE REPLACEMENT OF THE OTHER COMPONENTS WAS DONE IN AN ABUNDANCE OF CAUTION NO OTHER RELATED COMPONENTS WERE CONTRIBUTING TO THE BLOWN FUSE ON F2. THE UNIT WAS TESTED TO SPECIFICATIONS AND RETURNED TO THE CUSTOMER. NO FURTHER TRAINING IS REQUIRED. *PREVENTATIVE ACTION ACTIVITY COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS.

    Description of Event or Problem · 0

    BLOWS FUSE ON CONTROL BOARD. FS LOG#: 99014. LEEP SYSTEM 1000 ESU GEN. 52969 E-COMPLAINT-2022-08-0000483.

    Description of Event or Problem · 0

    BLOWS FUSE ON CONTROL BOARD. FS LOG #99014 1216677-2022-00253 LEEP SYSTEM 1000 ESU GEN. 52969 E-COMPLAINT-2022-08-0000483.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149169 LEEP SYSTEM 1000 ESU GEN. LEEP HGI COOPERSURGICAL, INC. 52969 NOT APPLICABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other