BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LL100 CRYOSURGICAL

    MDR report key: 5612433 · Received April 27, 2016

    Report

    Report Number
    1216677-2015-00054
    Event Type
    Malfunction
    Date Received
    April 27, 2016
    Date of Event
    July 16, 2015
    Report Date
    October 22, 2015
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 07/21/2015 COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. THE DEVICE INVOLVED IN THE COMPLAINT HAS BEEN RETURNED BY THE CUSTOMER FOR EVALUATION. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE FILED. (B)(4). ON 10/22/2015 1216677-2015-0054 FOLLOW-UP INVESTIGATION SUMMARY REPORT: REVIEW DHR: INSPECT RETURNED SAMPLES. A REVIEW OF THE 2 YR COMPLAINT HISTORY REVEALS SIMILAR ISSUES. A REVIEW OF THE DHR REVEALS NO ANOMALIES. THE DESCRIPTION NOTES THE DOCTOR'S HAND WAS BURNED AND THE HANDLE BLOW OUT. THE DESCRIPTION IS PARTIALLY CORRECT. THE HANDLE COULD NOT HAVE BLOWN OUT AS THE HANDLE WAS IN PLACE AND THE SCREWS HOLDING IT IN PLACE WERE NOT STRIPPED. NOR WAS THE HANDLE BROKEN. HOWEVER, THE TUBING DID BLOW OUT IN THE HANDLE. INITIAL FEEDBACK FROM THE CUSTOMER INDICATES THE UNIT FAILED IMMEDIATELY ON ITS FIRST USE AND THE UNIT FAILED WHEN THE FREEZE MODE WAS PRESSED. THE FLOW OF THE GAS INTO THE UNIT EXPOSES IT TO THE PRESSURE AND OCCURS FIRST. THE UNIT MUST HAVE HELD THE PRESSURE AND FAILED ONCE THE FREEZE MODE WAS PRESSED. THERE ARE NO OTHER DETAILS AVAILABLE. THE UNIT IS FITTED WITH P/N 105005 NYLON TUBING LOT #102814 WHICH IS NOT CLEAR. IT IS OPAQUE. THIS WAS CONFIRMED VISUALLY USING THE 10 DIGIT NUMBER ON THE TUBING, (B)(4). OUR INFORMATION FROM THE VENDOR INDICATES THIS TUBING WAS MADE WITH N10/12, THE LATEST RESIN THEY QUALIFIED TO MAKE NNR-2-026. CLEAR TUBING BURSTING IN THE FIELD RESULTED IN CAPA (B)(4) STILL IN PROGRESS. IT IS NOT UNDERSTOOD AT THIS TIME WHY THIS ONE UNIT HAS THE SAME FAILURE AS THE CLEAR MATERIAL. NO OTHER UNITS USING THIS LOT OF MATERIAL HAS SHOWN UP AS BURSTING IN THE FIELD. THE ROOT CAUSE FOR THIS COMPLAINT CONDITION IS NOT AVAILABLE. GIVEN THE RECENT CAPA THE INVESTIGATION WILL BE TAKEN FURTHER BY SUSTAINING ENGINEERING. THIS IS NOT AN ASSEMBLY ISSUE. COMPLAINTS WILL BE CONTINUOUSLY MONITORED TO DETERMINE IF THERE IS ANY NEW TREND FOR THIS COMPLAINT CONDITION.

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. THE DEVICE INVOLVED IN THE COMPLAINT HAS BEEN RETURNED BY THE CUSTOMER FOR EVALUATION. ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    "GUN BACKFIRED ONTO THE DOCTORS HAND. WHEN TURNED ON THE HANDLE BLEW OUT. DOCTOR BURNED HAND." (B)(4).

    Description of Event or Problem · 1

    "GUN BACKFIRED ONTO THE DOCTORS HAND. WHEN TURNED ON THE HANDLE BLEW OUT. DR BURNED HAND". (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269139 LL100 CRYOSURGICAL LL100 CRYOSURGICAL GEH COOPERSURGICAL, INC. 900001 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1