BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LM-900 N2O CE CRYOSURG SY

    MDR report key: 14186768 · Received April 22, 2022

    Report

    Report Number
    1216677-2022-00124
    Event Type
    Malfunction
    Date Received
    April 22, 2022
    Date of Event
    March 10, 2022
    Report Date
    June 6, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    PMA / PMN Number
    K854767
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COOPERSURGICAL , INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITON.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: REVIEW DHR: INSPECT RETURNED SAMPLES *ANALYSIS AND FINDINGS COMPLAINT (B)(4) DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 02/15/2013 UNDER WO # (B)(4) AND SHIPPED ON 03/12/2013. MANUFACTURING RECORD REVIEW: DHR (B)(4) 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 IN 2020 FOR DAMAGE TO THE HOUSING AND A WORN CONNECTOR HUB. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED SIMILAR REPORTED COMPLAINT CONDITION. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED ON A REPAIR. 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. CORRECTIVE ACTIONS: ALTHOUGH THE UNIT FUNCTIONED FREE OF DEFECTS THE UNIT'S TRIGGER ASSEMBLY WAS REPLACED PER THE CUSTOMER'S REQUEST, TESTED 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. NO FURTHER TRAINING IS REQUIRED. *WAS THE COMPLAINT CONFIRMED? NO.

    Description of Event or Problem · 0

    LEAKING ON TIP & HANDLE FOUND LM 900 WORKS TO SPECS. NO TIPS SENT IN WITH UNIT. REPLACED TRIGGER ASSY PER MIGUEL. REPAIR ORDER 98060 1216677-2022-00124 LM-900 N2O CE CRYOSURG SY 50501 E-COMPLAINT-(B)(4).

    Description of Event or Problem · 0

    LEAKING ON TIP & HANDLE FOUND LM 900 WORKS TO SPECS. NO TIPS SENT IN WITH UNIT. REPLACED TRIGGER ASSY PER MIGUEL. REPAIR ORDER 98060. 1216677-2022-00124-1 LM-900 N2O CE CRYOSURG SY 50501 E-COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2289828 LM-900 N2O CE CRYOSURG SY LM-900 N2O CE CRYOSURG SY GEH COOPERSURGICAL, INC. 50501 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other