BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STONEBREAKER SINGLE USE PROBE

    MDR report key: 7377182 · Received March 28, 2018

    Report

    Report Number
    1820334-2018-00812
    Event Type
    Malfunction
    Date Received
    March 28, 2018
    Report Date
    June 7, 2018
    Manufacturer
    COOK INC
    Product Code
    FFK
    UDI-DI
    00827002526051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION ¿ EVALUATION: A VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED. A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, QUALITY CONTROL DATA AND SPECIFICATIONS WAS ALSO PERFORMED. ONE UNOPENED PACKAGE LABELED RPN (B)(4), LABEL LOT NUMBER 7030045 WAS RECEIVED. VISUAL EXAMINATION OF THE SEALED PACKAGE CONFIRMED A DARK COLORED HAIR LOOSE INSIDE THE SEALED PACKAGE. REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NON-CONFORMANCES ASSOCIATED WITH THE REPORTED FAILURE MODE. A REVIEW OF COMPLAINT HISTORY REVEALED THERE ARE NO OTHER COMPLAINTS ASSOCIATED WITH THE COMPLAINT PRODUCT LOT NUMBER 7030045. A DOCUMENT REVIEW WAS CARRIED OUT AND IT WAS IDENTIFIED THAT THE PRODUCT LINE WAS INSPECTED FOR FOREIGN MATTER AFTER BEING PACKAGED. THERE WERE NO ADDITIONAL COMPLAINTS OR NON-CONFORMANCES IDENTIFIED ON THE SAME LOT. THE CAUSE OF THIS COMPLAINT IS MANUFACTURING RELATED. MEASURES HAVE BEEN INITIATED TO ADDRESS THIS FAILURE. COOK MEDICAL HAS NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 1

    COMMON NAME/ PRODUCT CODE: LITHOTRIPTOR, ELECTRO-HYDRAULIC/ FFL. PMA/510(K) #: K062475. (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN GATHERING PRODUCTS FOR A RECALL RESPONSE, A HAIR WAS OBSERVED IN THE STERILE PACKAGE OF THIS STONEBREAKER SINGLE USE PROBE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS REPORTED ISSUE. THE DEVICE DID NOT MAKE CONTACT WITH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219642 STONEBREAKER SINGLE USE PROBE FFK COOK INC 00827002526051

    Patients

    Seq Age Sex Outcome Treatment
    1