BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LL100 CRYOSURGICAL

    MDR report key: 13334244 · Received January 24, 2022

    Report

    Report Number
    1216677-2021-00336
    Event Type
    Malfunction
    Date Received
    January 24, 2022
    Date of Event
    November 30, 2021
    Report Date
    April 8, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    PMA / PMN Number
    K803311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    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: X-INSPECT RETURNED SAMPLES . ANALYSIS AND FINDINGS : COMPLAINT (B)(4). DISTRIBUTION HISTORY: AS PER SERVICE AND REPAIR, THE COMPLAINT UNIT IS FROM 1993. BASED ON THIS DATE, IT WAS MANUFACTURED AND DISTRIBUTED BY WALLACH SURGICAL DEVICES. MANUFACTURING RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY 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. SHOULD THE DEVICE HISTORY RECORD BE LOCATED GOING FORWARD THIS COMPLAINT WILL BE AMENDED ACCORDINGLY. 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 97752 THIS UNIT WAS AT CSI ON 12/20/2021. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT UNIT REVEALED PHYSICAL DAMAGE. THE UNIT IS LEAKING AT THE CONNECTOR DUE TO MIS-SHAPED N2O NIB. THE GAUGE HOUSING COVER IS BROKEN. PLATING WORN OFF OF THE CRYO TIP. FUNCTIONAL EVALUATION: COMPLAINT UNIT WAS FUNCTIONALLY EVALUATED AND FOUND NOT TO FUNCTION PROPERLY. WAS THE COMPLAINT CONFIRMED? YES. ROOT CAUSE: WHILE NO DEFINITIVE ROOT CAUSE COULD BE RELIABLY DETERMINED, THE ISSUE MAY BE DUE TO END USER MISHANDLING AND NORMAL WEAR AND TEAR. CORRECTION AND/OR CORRECTIVE ACTION: THE COMPLAINT UNIT WAS REPAIRED AND RETURNED TO THE CUSTOMER. THE CRYO TIP WAS REPLACED. COOPERSURGICAL WILL CONTINUE TO TREND THE COMPLAINT CONDITION. NO FURTHER CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    NITROUS LEAKING AT COPPER OVER PRESSURE RELIEF DEVICE OK. LEAKING AT CONNECT DUE TO WORN AND MIS-SHAPEN N2O NIB. BROKEN GAUGE HOUSING COVER. LEAKING O RINGS. PLATING WORN OFF OLD STYLE CRYO TIP. TIP NOT REPAIRABLE. REPAIR ORDER 97552 LL100 CRYOSURGICAL 900001 E-COMPLAINT-(B)(4).

    Description of Event or Problem · 0

    NITROUS LEAKING AT COPPER OVER PRESSURE RELIEF. RELIEF DEVICE OK. LEAKING AT CONNECT DUE TO WORN AND MIS-SHAPEN N2O NIB. BROKEN GAUGE HOUSING COVER. LEAKING O RINGS. PLATING WORN OFF OLD STYLE CRYO TIP. TIP NOT REPAIRABLE. REPAIR ORDER (B)(4). 1216677-2021-00336 LL100 CRYOSURGICAL 900001 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2177616 LL100 CRYOSURGICAL LL100 CRYOSURGICAL GEH COOPERSURGICAL, INC. 900001 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other