BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LL100 CRYOSURGICAL

    MDR report key: 13474874 · Received February 7, 2022

    Report

    Report Number
    1216677-2022-00031
    Event Type
    Malfunction
    Date Received
    February 7, 2022
    Date of Event
    January 14, 2022
    Report Date
    March 21, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    PMA / PMN Number
    K803311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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: INSPECT RETURNED SAMPLES. ANALYSIS AND FINDINGS: COMPLAINT: (B)(4). DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 03/26/2015 UNDER WO#: (B)(4) AND SHIPPED ON 04/20/2015. MANUFACTURING RECORD REVIEW: DHR-171743 WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW: NOT APPLICABLE. SERVICE HISTORY RECORD: THIS PRODUCT WAS RETURNED ON 12/14/2017 ON REPAIR LOG: (B)(4) FOR LEAKING AT THE BRASS CONNECTOR, THE UNIT WAS REPAIRED AND RETURNED TO THE CUSTOMER. 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: ROOT CAUSE NOT APPLICABLE AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. CORRECTIVE ACTIONS: THE UNIT WAS TESTED PER THE COOPER PROCEDURE AND WAS FOUND TO BE FUNCTIONING CORRECTLY. THE UNIT WAS RETURNED TO THE CUSTOMER. COOPER SURGICAL 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 REQUIRED AT THIS TIME. WAS THE COMPLAINT CONFIRMED? NO.

    Description of Event or Problem · 0

    WE HAVE 2 X UHM650 WHICH ARE RETURNED BACK TO US FROM CUSTOMERS. 1 X UMH650 LOT 29946720: THE METAL ROD ALLOWING MOBILITY OF THE END HAS BROKEN DURING THE PROCEDURE. 01/27/2022: FOLLOW-UP RESPONSE: WAS THERE ANY ADDITIONAL MEDICAL ATTENTION? NO MEDICAL ADDITIONAL ATTENTION. WHAT PROCEDURE WAS THE PHYSICIAN PERFORMING? LAPAROSCOPIC HYSTERECTOMY. DID THE PHYSICIAN PERFORM ANY EXTRA STEP TO COMPLETE THE PROCEDURE/HOW DID PHYSICIAN COMPLETE THE PROCEDURE/WAS THERE ANY FRAGMENT LEFT IN THE PATIENT? CHANGED THE UTERINE MANIPULATOR AND CONSUMABLES TO NEW ONES. NO FRAGMENTS REMAINED IN THE PATIENT. WAS THERE ANY SIGNIFICANT DELAY AS RESULT OF THE REPORTED CONDITION? 30 MINUTES. RUMI II BACKLOADABLE UMH650 (B)(4).

    Description of Event or Problem · 0

    LEAKING FROM NOZZLE/HANDLE. UNABLE TO VERIFY COMPLAINT. REPAIR ORDER: (B)(4). HISTORY: LEAKS AT HANDLE REPORTED. 1216677-2022-00031-1 LL100 CRYOSURGICAL 900001 E-COMPLAINT: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2923758 LL100 CRYOSURGICAL LL100 CRYOSURGICAL GEH COOPERSURGICAL, INC. 900001 N/A
    927781 LL100 CRYOSURGICAL LL100 CRYOSURGICAL GEH COOPERSURGICAL, INC. 900001 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| R| C| L| S