BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP ULTRA

    MDR report key: 1052233 · Received May 21, 2008

    Report

    Report Number
    1037905-2008-00062
    Event Type
    Malfunction
    Date Received
    May 21, 2008
    Report Date
    April 21, 2008
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    FCG
    PMA / PMN Number
    K934356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: WE WERE UNABLE TO CONFIRM THE REPORT AS IT WAS DESCRIBED BECAUSE THE AFFECTED PRODUCT WAS NOT RETURNED TO COOK ENDOSCOPY FOR EVAL. WE WERE UNABLE TO CONDUCT A REVIEW OF THE DEVICE HISTORY RECORD OR CONDUCT A SAMPLE TEST FROM THIS LOT BECAUSE THE LOT NUMBER WAS UNABLE TO BE PROVIDED. AFTER A REVIEW OF THE ACCOUNT ORDER HISTORY, THE LOT NUMBER WAS UNABLE TO BE DETERMINED. A REVIEW OF THE TWELVE MONTH COMPLAINT HISTORY FOR THIS PRODUCT FAMILY WAS CONDUCTED. THIS REPORT REPRESENTS AN UNUSUAL OCCURRENCE. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS REMOTE. CONCLUSIONS: WE WERE UNABLE TO CONDUCT A FULL INVESTIGATION BECAUSE THE DEVICE WAS NOT RETURNED FOR EVAL. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION WAS UNABLE TO BE DETERMINED. HOWEVER, WE CAN PROVIDE THE FOLLOWING COMMENTS: THE INSTRUCTIONS FOR USE FOR THIS PRODUCT LINE ADVISE THE USER TO ADJUST THE NEEDLE TO THE DESIRED LENGTH BY LOOSENING THE THUMBSCREW ON THE SAFETY RING AND ADVANCING IT UNTIL THE DESIRED REFERENCE MARK FOR NEEDLE ADVANCEMENT APPEARS IN THE WINDOW OF THE SAFETY RING. THE INSTRUCTIONS THEN DIRECT THE USER TO TIGHTEN THE THUMBSCREW TO LOCK THE SAFETY RING IN PLACE. PRIOR TO DISTRIBUTION, THE THUMBSCREW OF THE HANDLE IS TIGHTENED AND LOOSENED DURING THE INSPECTION STAGE. ALL ENDOSCOPIC ULTRASOUND NEEDLES ARE SUBJECTED TO THIS TEST TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: THE COMPLAINT RISK PRIORITY NUMBER (CRPN) FOR THIS TYPE OF OCCURRENCE HAS BEEN CALCULATED BASED ON THE RATE OF OCCURRENCE AND SEVERITY OF THE OUTCOME. BASED ON THIS ACTIVITY, NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. NO FURTHER ACTION WARRANTED AT THIS TIME BECAUSE THIS REPORT WAS UNABLE TO BE VERIFIED. THIS OBSERVATION REPRESENTS AN UNUSUAL OCCURRENCE. THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS REMOTE. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPIC ULTRASOUND PROCEDURE, THE PHYSICIAN USED A COOK ENDOSCOPY ECHOTIP ULTRA. AFTER ONE BIOPSY, THE THUMBSCREW DID NOT FASTEN TIGHT ENOUGH TO HOLD THE HANDLE IN PLACE. THE USER COMMENTED THAT SOMEONE MAY INADVERTENTLY ADVANCE THE HANDLE. THE NEEDLE WAS DISCARDED AND ANOTHER NEEDLE WAS USED TO FINISH THE PROCEDURE SUCCESSFULLY. A FOREIGN OBJECT DID NOT HAVE TO BE RETRIEVED FROM THE PT. NO ADD'L MEDICAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHOTIP ULTRA FCG SET, BIOPSY NEEDLE AND NEEDLE, GASTRO-UROLOGY FCG COOK ENDOSCOPY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1