BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LM-900 N2O CE CRYOSURG SY

    MDR report key: 11950196 · Received June 7, 2021

    Report

    Report Number
    1216677-2021-00126
    Event Type
    Malfunction
    Date Received
    June 7, 2021
    Date of Event
    March 9, 2021
    Report Date
    January 24, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    UDI-DI
    00888937009965
    PMA / PMN Number
    K854767
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION REVIEW DHR INSPECT RETURNED SAMPLES DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 05/22/2015 UNDER WO #(B)(4) AND SHIPPED ON 1/29/2016. MANUFACTURING RECORD REVIEW: DHR 172479 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. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT UNIT REVEALED EXTENSIVE PHYSICAL DAMAGE. FUNCTIONAL EVALUATION: COMPLAINT UNIT WAS FUNCTIONALLY EVALUATED AND FOUND NOT TO FUNCTION PROPERLY. ROOT CAUSE: THE CONDITION OF THE UNIT ALIGNS WITH THE PROBLEM DESCRIPTION. DUE TO THE DAMAGE FOUND ON THE UNIT, THE ROOT CAUSE IS BEING ATTRIBUTED TO HANDLING ERROR. CORRECTIVE ACTION THE UNIT WAS EVALUATED AND CONFIRMED TO HAVE BEEN EXPOSED TO EXCESSIVE FORCE WHEN HANDLED. THE CUSTOMER ELECTED TO HAVE THE UNIT SCRAPPED OUT AND NOT HAVE IT RETURNED. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY. NO FURTHER TRAINING AT THIS TIME. WAS THE COMPLAINT CONFIRMED? YES.

    Description of Event or Problem · 0

    CUSTOMER STATED: "DELAY IN CO2 REACHING TIP AND IN RELEASE. PRESSURE GAUGE SEEMS TO BE WORKING. THERE IS ONLY THE DELAY IN CO2 REACHING THE TIP TO PROCEED WITH PROCEDURE AND DELAY IN 'THAWING' OF THE TIP WHEN PRESSURE IS RELEASED". 1216677-2021-00126-1 50501 LM-900 N20 CE CRYOSURG SY (B)(4)

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Description of Event or Problem · 1

    CUSTOMER STATED: DELAY IN CO2 REACHING TIP AND IN RELEASE. PRESSURE GAUGE SEEMS TO BE WORKING. THERE IS ONLY THE DELAY IN CO2 REACHING THE TIP TO PROCEED WITH PROCEDURE AND DELAY IN 'THAWING' OF THE TIP WHEN PRESSURE IS RELEASED. COMPLAINT CONFIRMED: TUBE TIP CRIMPED, HOSE OUTER SHEATH HAS SEVERAL CUTS AND IS TAPED. NIPPLE CONNECT SEAL DAMAGED AND WILL NOT SEAL TO TANK. GAUGE COVER CRACKED. RO (B)(4). LM-900 N2O CE CRYOSURG SY 50501. E-COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849644 LM-900 N2O CE CRYOSURG SY LM-900 N2O CE CRYOSURG SY GEH COOPERSURGICAL, INC. 50501 N/A 00888937009965

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other