BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LL100 CRYOSURGICAL

    MDR report key: 13064076 · Received December 22, 2021

    Report

    Report Number
    1216677-2021-00282
    Event Type
    Malfunction
    Date Received
    December 22, 2021
    Date of Event
    October 18, 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
    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

    INVESTIGATION: X-INITIATED MANUFACTURER'S INVESTIGATION X-INSPECT RETURNED SAMPLES. ANALYSIS AND FINDINGS; DISTRIBUTION HISTORY: THE COMPLAINT PRODUCT WAS MANUFACTURED AT CSI ON 02-07-11 UNDER WORK ORDER (B)(4) AND SOLD ON 02-25-11. 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: INCOMING INSPECTION RECORD REVIEW NOT APPLICABLE TO THIS PRODUCT. SERVICE HISTORY RECORD: NO SERVICE HISTORY RECORD FOUND FOR THIS PRODUCT. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED SIMILAR REPORTED COMPLAINT CONDITIONS. THERE ARE ADDITIONAL INSTANCES OF BROKEN TUBING, TRIGGERS AND LOOSE N20 NIPPLES. THESE CONDITIONS ARE USUALLY ATTRIBUTED TO IMPACT DAMAGE OR WEAR AND TEAR. PRODUCT RECEIPT: THE COMPLAINT PRODUCT (P/N 900001, S/N (B)(6)) WAS RETURNED ON 10-21-21. THE SERIAL NUMBER OF THE RETURNED PRODUCT MATCHED THE SERIAL NUMBER REPORTED. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT PRODUCT REVEALED PHYSICAL DAMAGE. THE UNIT WAS FOUND TO HAVE A BROKEN INSULATOR TUBE AND DEFROST TRIGGER. FUNCTIONAL EVALUATION: COMPLAINT PRODUCT WAS FUNCTIONALLY EVALUATED AND FOUND NOT TO FUNCTION PROPERLY. THE UNIT WAS DAMAGED AND HAD A LOOSE N20 NIPPLE. WAS THE COMPLAINT CONFIRMED? YES. ROOT CAUSE: WHILE NO DEFINITIVE ROOT CAUSE COULD BE RELIABLY DETERMINED, THE POTENTIAL CAUSE MAY BE A COMBINATION OF WEAR AND TEAR DUE TO THE AGE OF THE UNIT AS WELL AS IMPACT DAMAGE. CORRECTION AND/OR CORRECTIVE ACTION: THE COMPLAINT UNIT WAS REPAIRED AND RETURNED TO THE CUSTOMER. COOPERSURGICAL WILL CONTINUE TO TREND THIS COMPLAINT CONDITION.

    Description of Event or Problem · 0

    BROKEN AND LEAKING. CONFIRMED COMPLAINT: BROKEN INSULATOR TUBE AND DEFROST TRIGGER. LOOSE N2O NIPPLE. REPAIR ORDER (B)(4). LL100 CRYOSURGICAL 900001 E-COMPLAINT- (B)(4).

    Description of Event or Problem · 0

    BROKEN AND LEAKING. CONFIRMED COMPLAINT: BROKEN INSULATOR TUBE AND DEFROST TRIGGER. LOOSE N2O NIPPLE. REPAIR ORDER (B)(4). 1216677-2021-00282 LL100 CRYOSURGICAL 900001 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1967673 LL100 CRYOSURGICAL LL100 CRYOSURGICAL GEH COOPERSURGICAL, INC. 900001 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other