BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LL100 SHORT SHAFT N20 FRZ

    MDR report key: 10190392 · Received June 24, 2020

    Report

    Report Number
    1216677-2020-00136
    Event Type
    Malfunction
    Date Received
    June 24, 2020
    Date of Event
    March 23, 2020
    Report Date
    July 28, 2020
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    PMA / PMN Number
    K803311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION X-INSPECT RETURNED SAMPLES. ANALYSIS AND FINDINGS COMPLAINT (B)(4). DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI IN 1999. 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: 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 NO SIMILAR REPORTED COMPLAINT CONDITION. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED ON A REPAIR. HOWEVER, BASED ON LOG (B)(4), THIS UNIT WAS AT CSI ON (B)(6) 2020. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT UNIT REVEALED NO PHYSICAL DAMAGE. FUNCTIONAL EVALUATION: COMPLAINT UNIT WAS FUNCTIONALLY EVALUATED AND FOUND NOT TO FUNCTION PROPERLY. SERVICE & REPAIR CONFIRMED THE COMPLAINT UNIT'S INLET TUBE ASSEMBLY WAS BLOCKED AND CONSISTENT WITH THE PROBLEM DESCRIPTION ON THE COMPLAINT. ROOT CAUSE: THE ROOT CAUSE OF THIS ISSUE HAS BEEN ATTRIBUTED TO WEAR AND TEAR BEING IN SERVICE FOR SO LONG. THE REASON FOR THE BLOCKAGE WAS NOT DETERMINED BUT PROBABLY BUILD UP OVER THE YEARS OR FROM A PARTICULATE THAT GOT LODGED INSIDE. CORRECTION AND/OR CORRECTIVE ACTION THE UNIT WAS NOT REPAIRED AS IT IS AN OBSOLETE DESIGN NO LONGER SUPPORTED BY CSI. IT WAS RETURNED AS-IS TO THE CUSTOMER. REVIEW AND CLOSURE: FAULT CODE: NO FAULT . FAILURE CODE: WEAR AND TEAR . PREVENTATIVE ACTION ACTIVITY : COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS.

    Description of Event or Problem · 0

    THE DEFROSTER WILL NOT DEFROST. ORDER: (B)(4). E-COMPLAINT (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION.

    Description of Event or Problem · 1

    THE DEFROSTER WILL NOT DEFROST. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655969 LL100 SHORT SHAFT N20 FRZ LL100 SHORT SHAFT N20 FRZ GEH COOPERSURGICAL, INC. 900020 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other