BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEEP SYSTEM 1000 ESU GEN

    MDR report key: 10754783 · Received October 29, 2020

    Report

    Report Number
    1216677-2020-00249
    Event Type
    Malfunction
    Date Received
    October 29, 2020
    Date of Event
    October 16, 2020
    Report Date
    October 29, 2020
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    PMA / PMN Number
    K952483
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION X-INSPECT RETURNED SAMPLES *ANALYSIS AND FINDINGS COMPLAINT 2020-10-0000273 DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 8/9/2010 UNDER WO #93823 AND SHIPPED ON 8/12/2010. MANUFACTURING RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS THE RECORD COULD NOT BE LOCATED AT THE TIME OF THIS INVESTIGATION. HOWEVER, IT SHOULD BE NOTED AT THE TIME OF MANUFACTURE RECORDS FROM EACH LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL COOPERSURGICAL QUALITY RELEASE SPECIFICATIONS. SHOULD THE DEVICE HISTORY RECORD BE LOCATED GOING FORWARD, IT WILL BE REVIEWED, AND THIS COMPLAINT AMENDED ACCORDINGLY. INCOMING INSPECTION REVIEW: NOT APPLICABLE. SERVICE HISTORY RECORD: THIS UNIT WAS UPDATED WITH A NEW DIAPHRAGM UNDER LOG 92069 ON 5/28/2019. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED SIMILAR REPORTED COMPLAINT CONDITIONS. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED ON REPAIR LOG 95050. 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 TESTED TO SPECIFICATIONS AND RETURNED TO THE CUSTOMER. 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 TRENDS.

    Description of Event or Problem · 0

    REF: E-COMPLAINT-2020-10-0000273 REPORT STATED "BLEEDING THAN NORMAL DUE TO PROLONGED PROCEDURE". PER TECH'S UNIT WAS FUNCTIONAL. - REPAIR ORDER 95090. 1216677-2020-00249 LEEP SYSTEM 1000 ESU GEN 52969 E-COMPLAINT-2020-10-0000273.

    Additional Manufacturer Narrative · 1

    COOPER SURGICAL , INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Description of Event or Problem · 1

    REF: (B)(4). REPORT STATED, "BLEEDING THAN NORMAL DUE TO PROLONGED PROCEDURE." PER TECH'S UNIT WAS FUNCTIONAL; REPAIR ORDER: (B)(4). 1216677-2020-00249 LEEP SYSTEM; 1000 ESU GEN 52969 ; E-COMPLAINT: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1220094 LEEP SYSTEM 1000 ESU GEN LEEP SYSTEM 1000 ESU GEN HGI COOPERSURGICAL, INC. 52969 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other