BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NGAGE NITINOL STONE EXTRACTOR

    MDR report key: 7714464 · Received July 24, 2018

    Report

    Report Number
    1820334-2018-02136
    Event Type
    Malfunction
    Date Received
    July 24, 2018
    Date of Event
    July 13, 2018
    Report Date
    August 14, 2018
    Manufacturer
    COOK INC
    Product Code
    FFL
    UDI-DI
    00827002482944
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION/EVALUATION: A VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED. A DOCUMENT BASED INVESTIGATION WAS ALSO PERFORMED. THIS INCLUDED A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL DATA. ONE UNOPENED DEVICE WAS RETURNED FOR INVESTIGATION. A VISUAL EXAMINATION OF THE SEALED PACKAGE NOTED THE DEVICE HAS COME LOOSE AND THE BASKET SHEATH WAS PROTRUDING FROM THE PROPER PLACEMENT IN THE SHIPPING TRAY. IN CONCLUSION, THE FAILURE NOTED WAS THE RESULT OF SHIPPING/TRANSPORTATION. THE DEVICE HISTORY LOT RECORD NOTED THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER. A SEARCH OF COMPLAINT RECORDS FOUND THIS IS THE ONLY COMPLAINT ASSOCIATED WITH LOT NUMBER: 7021335. A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS WAS CONDUCTED. IT WAS CONCLUDED THAT THE DEVICE ASPECT IN QUESTION WAS VISUALLY/FUNCTIONALLY INSPECTED BY QUALITY CONTROL AND NO RELATED GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE NOTED. THE COMPLAINT DEVICE WAS REPORTED TO HAVE A SHEATH DAMAGED DUE TO THE DEVICE COMING OUT OF THE TRAY WHILE STILL INSIDE THE PACKAGING. THE DEVICE WAS MANUFACTURED JUNE OF 2016, USING AN OLDER TRAY MOLD. THE TRAY MOLD WAS REPLACED 21FEB2018 TO IMPROVE THE FUNCTIONALITY OF THE TRAY. IT WAS DETERMINED THAT WEAR IN THE MOLD THAT PRODUCED THE TRAYS REDUCED THE ABILITY OF THE TRAY TO STAY SNAPPED SHUT. THE INVESTIGATION CAUSE FOR THIS COMPLAINT IS CAUSE TRACED TO MANUFACTURING: MANUFACTURING DEFICIENCY - SUPPLIER. THE ISSUE HAS BEEN PREVIOUSLY ADDRESSED WITH THE SUPPLIER, NO FURTHER ACTION IS NECESSARY. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. COOK MEDICAL HAS NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 25-JUL-2018. THIS ISSUE WAS FOUND DURING PREPARATION OF THE DEVICE FOR TRANSURETHRAL LITHOTRIPSY (TUL) PLANNED TO BE PERFORMED IN THE FUTURE. NO SPECIFIC PERSON HAS BEEN IDENTIFIED YET AT THAT STAGE. WHEN THE PERSON IN CHARGE OF PREPARING THE DEVICES USED FOR THE PROCEDURE CHECKED THE COMPLAINT DEVICE, IT WAS FOUND THAT THE HANDLE HAD BEEN DETACHED FROM THE TRAY AND WAS MOVING FREELY IN THE PACKAGE. ALSO DAMAGE IN THE BASKET SHEATH WAS NOTED.

    Additional Manufacturer Narrative · 1

    (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 THE PHYSICIAN WAS CONDUCTING A PREPARATION OF THE NGE-017115 PRIOR TO USE, DAMAGE IN THE TIP OF THE BASKET OF IT WAS FOUND. AS REPORTED, THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555179 NGAGE NITINOL STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC 7021335 00827002482944

    Patients

    Seq Age Sex Outcome Treatment
    1