BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LM-900 N2O CE CRYOSURG SY

    MDR report key: 14945670 · Received July 7, 2022

    Report

    Report Number
    1216677-2022-00152
    Event Type
    Malfunction
    Date Received
    July 7, 2022
    Date of Event
    April 13, 2022
    Report Date
    August 3, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    PMA / PMN Number
    K803311
    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 CONDITION.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA SUBMISSION NAME : 1216677-2022-00152 LM-900 N2O CE CRYOSURG SY 50501 E-COMPLAINT-(B)(4).1216677-2022-00152 LM-900 N2O CE CRYOSURG SY 50501 E-COMPLAINT-(B)(4). PREVIOUSLY REPORTED AS 1216677-2022-00152 LL100 CRYOSURGICAL 900001 E-COMPLAINT-(B)(4). INVESTIGATION. X-REVIEW DHR . X-INSPECT RETURNED SAMPLES . *ANALYSIS AND FINDINGS . COMPLAINT (B)(4). DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 02/14/2014 UNDER WO #(B)(4) AND SHIPPED ON 2/20/2014. MANUFACTURING RECORD REVIEW: DHR 156663 WAS 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 THE 2-YEAR COMPLAINT HISTORY SHOWED SIMILAR REPORTED COMPLAINT CONDITION. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED ON A REPAIR. HOWEVER, BASED ON LOG (B)(4), THIS UNIT WAS AT CSI ON 5/09/2022. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT UNIT REVEALED NO PHYSICAL DAMAGE. FUNCTIONAL EVALUATION: COMPLAINT UNIT (P/N 50501) WAS FUNCTIONALLY EVALUATED AND FOUND TO FUNCTION PROPERLY. THE TIPS WERE NOTED TO NOT FUNCTION. ROOT CAUSE: THE LM900 WAS TESTED TO SPECIFICATION AS THE DEVICE WAS FOUND TO MEET ALL VISUAL AND FUNCTIONAL TEST SPECIFICATIONS. ROOT CAUSE NOT APPLICABLE IN REGARD TO THE LM900, P/N 50501. PERTAINING TO THE TIPS PROVIDED P/N'S 50105 & 50107: THE TIPS WERE DETERMINED TO BE THE SOURCE OF THE LEAK DESCRIBED IN THE COMPLAINT BUT ONLY IN REGARD TO THE LEAK AT THE TIP. LEAKS DUE THE TIPS INDICATES THE END USER INAPPROPRIATELY STERILIZED THE THEM SUCH AS AUTOCLAVING THEM OR PHYSICALLY DAMAGING THEM. *WAS THE COMPLAINT CONFIRMED? YES . *CORRECTION AND/OR CORRECTIVE ACTION. THE UNIT WAS EVALUATED, TESTED AND RETURNED TO THE CUSTOMER. THE TIPS WERE REPLACED WITH NEW UNITS FROM FG. 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

    LEAKING AT THE TRIGGER AND TIP CONNECTION. FOUND LM-900 GOOD, TIPS ARE LEAKING. SERVICE & REPAIR ORDER LOG 98385. LL100 CRYOSURGICAL 900001 (B)(4).

    Description of Event or Problem · 0

    LEAKING AT THE TRIGGER AND TIP CONNECTION FOUND LM-900 GOOD, TIPS ARE LEAKING. SERVICE & REPAIR ORDER LOG (B)(4). 1216677-2022-00152 LM-900 N2O CE CRYOSURG SY 50501 E-COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2087254 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