BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LL100 CRYOSURGICAL

    MDR report key: 8764408 · Received July 5, 2019

    Report

    Report Number
    1216677-2019-00193
    Event Type
    Malfunction
    Date Received
    July 5, 2019
    Date of Event
    June 17, 2019
    Report Date
    December 17, 2019
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    PMA / PMN Number
    K803311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE: (B)(4). *INVESTIGATION: X-REVIEW DHR. X-INSPECT RETURNED SAMPLES. X-INSPECT STOCK PRODUCT. *ANALYSIS AND FINDINGS: A REVIEW OF THE 2 YR COMPLAINT HISTORY REVEALS NO SIMILAR ISSUES. A REVIEW OF THE DHR REVEALS NO ANOMALIES. SERVICE & REPAIR CONFIRMED THE COMPLAINT. THE UNIT WAS FOUND TO HAVE ACTUATORS TOO LONG AND HIT ON THE HANDLES PREVENTING THE VALVE FROM SHUTTING OFF. THE ACTUATORS ARE PART OF THE VALVE ASSEMBLY WHICH CONTROLS THE FROST AND DEFROST MODES. THE FINDING INDICATING THE ACTUATORS WERE TOO LONG MEANS THE PLACEMENT WAS INCORRECT. THE ROOT CAUSE FOR THIS COMPLAINT CONDITION IS ASSEMBLY ERROR. CORRECTIVE ACTIONS: *CORRECTION AND/OR CORRECTIVE ACTION THE UNIT WAS RE-WORKED UNDER WO #272913 AND RE-STOCKED. DUE TO THE ASSEMBLER'S NEGLIGENCE ON THIS ONE UNIT, AND OTHER PRODUCTS, FG UNITS OF P/N 900001 WERE CHECKED FOR PROPER FUNCTION. NO ADDITIONAL FINDINGS WITH A SIMILAR LEVEL OF DEFECT WERE FOUND. A REVIEW OF THE ASSEMBLY METHOD CONFIRMS DETAILED INSTRUCTION ON THE HEIGHT SETTING FOR THE ACTUATORS IS WELL WRITTEN. THERE IS NO AMBIGUITY ABOUT THE CONTENT. THE ROOT CAUSE FOR THIS COMPLAINT CONDITION IS SPECIFICALLY ATTRIBUTABLE TO THE ASSEMBLER'S LACK OF SKILL. THIS ASSEMBLER IS NO LONGER A CSI EMPLOYEE. ISOLATED INCIDENT. NO APPLICABLE CORRECTION TO THE ASSEMBLY PROCEDURE IS REQUIRED. *WAS THE COMPLAINT CONFIRMED? YES. *PREVENTATIVE ACTION ACTIVITY: COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR ANY TRENDS.

    Description of Event or Problem · 0

    PHONE COMPLAINT: OUT OF BOX FAILURE....CUSTOMER WENT TO MAKE SURE THE PRODUCT WAS WORKING AND WHEN THEY DID THE NITROGEN WOULD SPRAY EVERYWHERE. REF: (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. ONCE THE INVESTIGATION PROCESS IS COMPLETED A FOLLOW-UP REPORT WILL BE FILED. REFERENCE E-COMPLAINT : (B)(4).

    Description of Event or Problem · 1

    PHONE COMPLAINT: OUT OF BOX FAILURE, CUSTOMER WENT TO MAKE SURE THE PRODUCT WAS WORKING AND WHEN THEY DID THE NITROGEN WOULD SPRAY EVERYWHERE. REF E-COMPLAINT: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559380 LL100 CRYOSURGICAL LL100 CRYOSURGICAL GEH COOPERSURGICAL, INC. 900001 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other