BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NGAGE NITINOL STONE EXTRACTOR

    MDR report key: 8102105 · Received November 26, 2018

    Report

    Report Number
    1820334-2018-03387
    Event Type
    Malfunction
    Date Received
    November 26, 2018
    Date of Event
    November 7, 2018
    Report Date
    January 10, 2019
    Manufacturer
    COOK INC
    Product Code
    FFL
    UDI-DI
    00827002482968
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION EVALUATION: A VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE RETURNED DEVICE WAS CONDUCTED. A DOCUMENT BASED INVESTIGATION WAS ALSO PERFORMED INCLUDING A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL DATA, AND SPECIFICATIONS. ONE STONE EXTRACTOR WAS RETURNED FOR INVESTIGATION. THE DEVICE WAS RETURNED WITH THE HANDLE BETWEEN THE OPEN AND CLOSED POSITIONS. THE MALE LUER LOCK ADAPTER (MLLA) IS FINGER TIGHT. THE COLLET KNOB IS TIGHT AND SECURE. THE POLYETHYLENE TEREPHTHALATE TUBING [PETT] MEASURES 1.5 CM IN LENGTH. VISUAL EXAMINATION NOTES THE BASKET SHEATH IS BENT 3 MM FROM DISTAL TIP OF THE SUPPORT SHEATH. THE SUPPORT SHEATH AND BASKET SHEATH ARE DETACHED. FUNCTIONAL TESTING DETERMINED THE HANDLE DOES NOT ACTUATE THE BASKET FORMATION. A REVIEW OF THE DEVICE HISTORY RECORD SHOWS THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER. A REVIEW OF COMPLAINT HISTORY RECORDS REVEALED THIS COMPLAINT IS THE ONLY ONE ASSOCIATED WITH LOT NUMBER 9190154. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU): CAUTION: THIS DEVICE IS CONDUCTIVE. AVOID CONTACT WITH ANY ELECTRIFIED INSTRUMENT. CAUTION: STERILE IF THE PACKAGE IS UNOPENED OR UNDAMAGED. DO NOT USE IF PACKAGE IS BROKEN. IMPORTANT: ENCLOSE DEVICE IN SHEATH BEFORE REMOVING FROM TRAY/HOLDER. IMPORTANT: EXCESSIVE FORCE COULD DAMAGE DEVICE. 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 SHEATH DAMAGE PREVENTED THE BASKET FROM FUNCTIONING NORMALLY. IT IS LIKELY THE SHEATH OF THE DEVICE WAS INADVERTENTLY DAMAGED DURING UNPACKING OR HANDLING OF THE DEVICE. DEVICES ARE INSPECTED FOR DAMAGE AND FUNCTIONALITY PRIOR TO PACKAGING. THE INVESTIGATION CONCLUSION IS CAUSE TRACED TO THE USER; UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO THE EVENT. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER RISK MITIGATING ACTIVITY IS REQUIRED. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED AND WE WILL CONTINUE TO MONITOR 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

    THERE HAS BEEN NO NEW INFORMATION RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(6). PMA/510K # ¿ EXEMPT . (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, WHILE PREPARING FOR A FLEXIBLE URETEROSCOPY (URS), THE NGAGE NITINOL STONE EXTRACTOR WAS OPENED, THEY TESTED THE DEVICE AND DISCOVERED THE BASKET WOULD NOT OPEN. ANOTHER SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    941993 NGAGE NITINOL STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC 9190154 00827002482968

    Patients

    Seq Age Sex Outcome Treatment
    1