BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEEP PRECISION INTG. SYS.

    MDR report key: 8792607 · Received July 16, 2019

    Report

    Report Number
    1216677-2019-00200
    Event Type
    Malfunction
    Date Received
    July 16, 2019
    Date of Event
    July 2, 2019
    Report Date
    December 17, 2019
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    PMA / PMN Number
    K963348
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    REF: (B)(4). INVESTIGATION: X-REVIEW DHR. X-INSPECT RETURNED SAMPLES. ANALYSIS AND FINDINGS: A REVIEW OF THE 2 YR COMPLAINT HISTORY REVEALS SIMILAR ISSUE. A REVIEW OF THE DHR REVEALS NO ANOMALIES. SERVICE & REPAIR DID NOT CONFIRM THE COMPLAINT. THE UNIT FUNCTIONED WITH NO FUNCTIONAL ISSUES. THE COMPLAINT DESCRIPTION IS VAGUE AND DOES NOT SPECIFY WHICH MODE WAS NOT FUNCTIONING OR IF ALL MODES WERE NOT WORKING. IT INDICATED THERE WAS AN INTERMITTENT ISSUE WITH THE UNIT TURNING ON WHICH WAS NOT CONFIRMED. THERE IS NO ROOT CAUSE FOR THIS COMPLAINT CONDITION. IT IS HIGHLY LIKELY THE END USER WAS NOT PROPERLY OPERATING THE DEVICE. THIS UNIT IS ON RECALL 1216677-05-24-2019-002-R FOR THE POTENTIAL TO HAVE AN OVERLOADED C21 DUE TO EXCESSIVE CURRENT ABOVE THE CAPACITORS' RATING. THIS FAILURE IS SPECIFICALLY FOR LOSS OF FOOT PEDAL FUNCTION. A DEVICE CAN STILL PRODUCE AN OUTPUT USING A HAND PIECE. THE CORRECTION APPLIED TO A UNIT IS ON THE MAIN DISPLAY PORTION OF THE BOARD BY INSTALLING A DIODE ON C21. THIS UNIT WAS NOT RETURNED FOR A FOOT PEDAL FAILURE NOR DID IT EXHIBIT THIS FAILURE UPON EVALUATION. CORRECTION AND/OR CORRECTIVE ACTION: THE UNIT WAS RETURNED TO THE CUSTOMER AFTER THE BOARD WAS UPDATED. A RECOMMENDATION TO HAVE AN IN-SERVICE VISIT MADE ON THIS CUSTOMER WAS SENT TO BOTH MARKETING AND PRODUCT SURVEILLANCE TO PROVIDE GUIDANCE AS NEEDED. THE UNIT WAS NOTED TO BE ON THE RECALL LIST AND SUBSEQUENTLY PROCESSED FOR RE-WORK UNDER WO #273866 TO ADD THE DIODE TO C21 AND TEST. UPON COMPLETION THE UNIT WAS PROCESSED FOR A RETURN TO THE SAME CUSTOMER. CAPA 725 WAS ISSUED AND A RECALL (1216677-05-24-2019-002-R) WILL ADDRESS THE REMAINING UNITS FROM THE IMPLEMENTATION OF THE ROHS BOARD INTO PRODUCTION UP TO THE ADDITION OF THE ZENER DIODE UNDER ECN-21881. WAS THE COMPLAINT CONFIRMED? NO.

    Description of Event or Problem · 0

    MACHINE DOESN'T ALWAYS TURN ON. REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. THE DEVICE INVOLVED IN THE COMPLAINT WILL BE RETURNED BY THE CUSTOMER AND EVALUATED. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    MACHINE DOESN'T ALWAYS TURN ON. REFERENCE E-COMPLAINT: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588545 LEEP PRECISION INTG. SYS. LEEP PRECISION INTG. SYS. HGI COOPERSURGICAL, INC. LP-10-120 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other