BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NGAGE NITINOL STONE EXTRACTOR

    MDR report key: 7424590 · Received April 12, 2018

    Report

    Report Number
    1820334-2018-00964
    Event Type
    Malfunction
    Date Received
    April 12, 2018
    Date of Event
    March 28, 2018
    Report Date
    May 7, 2018
    Manufacturer
    COOK INC
    Product Code
    FFL
    UDI-DI
    00827002482975
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION - EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE, QUALITY CONTROL DATA, AND SPECIFICATIONS WAS ALSO PERFORMED. ONE DEVICE WAS RETURNED FOR INVESTIGATION. THE DEVICE WAS RETURNED WITH THE HANDLE IN THE CLOSED POSITION AND THE BASKET FORMATION WAS RETURNED PARTIALLY CLOSED. THE COLLET KNOB IS TIGHT AND SECURE. THE MALE LUER LOCK ADAPTOR (MLLA) IS TIGHT. THE POLYETHYLENE TEREPHTHALATE TUBING (PETT) MEASURES 4 CM IN LENGTH. THE SUPPORT SHEATH AND BASKET SHEATH ARE STILL ADHERED. A FUNCTIONAL TEST WAS PERFORMED AND IT WAS NOTED THAT WHEN THE BASKET SHEATH IS IN THE STRAIGHT POSITION THE HANDLE ACTUATES THE BASKET FORMATION TO THE FULLY OPEN AND COMPLETELY CLOSED POSITIONS. BUT, WHEN THE BASKET SHEATH IS COILED THE BASKET FORMATION DOES NOT COMPLETELY RETRACT. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE. A REVIEW OF COMPLAINT HISTORY REVEALED THIS COMPLAINT IS THE ONLY ONE ASSOCIATED WITH LOT NUMBER 8182046. THE INSTRUCTIONS FOR USE (IFU) PROVIDES THE FOLLOWING: 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 COMPLAINT DEVICE WAS FOUND TO HAVE A NON-FULLY FUNCTIONING BASKET DUE TO SHEATH DAMAGE. DEVICES ARE INSPECTED FOR DAMAGE AND FUNCTIONALITY PRIOR TO PACKAGING. THE CAUSE FOR THE OBSERVED ISSUE COULD NOT BE DETERMINED. MEASURES HAVE BEEN INITIATED TO ADDRESS THIS FAILURE MODE. 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. INVESTIGATION - EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE, QUALITY CONTROL DATA, AND SPECIFICATIONS WAS ALSO PERFORMED. ONE DEVICE WAS RETURNED FOR INVESTIGATION. THE DEVICE WAS RETURNED WITH THE HANDLE IN THE CLOSED POSITION AND THE BASKET FORMATION WAS RETURNED PARTIALLY CLOSED. THE COLLET KNOB IS TIGHT AND SECURE. THE MALE LUER LOCK ADAPTOR (MLLA) IS TIGHT. THE POLYETHYLENE TEREPHTHALATE TUBING (PETT) MEASURES 4 CM IN LENGTH. THE SUPPORT SHEATH AND BASKET SHEATH ARE STILL ADHERED. A FUNCTIONAL TEST WAS PERFORMED AND IT WAS NOTED THAT WHEN THE BASKET SHEATH IS IN THE STRAIGHT POSITION THE HANDLE ACTUATES THE BASKET FORMATION TO THE FULLY OPEN AND COMPLETELY CLOSED POSITIONS. BUT, WHEN THE BASKET SHEATH IS COILED THE BASKET FORMATION DOES NOT COMPLETELY RETRACT. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE. A REVIEW OF COMPLAINT HISTORY REVEALED THIS COMPLAINT IS THE ONLY ONE ASSOCIATED WITH LOT NUMBER 8182046. THE INSTRUCTIONS FOR USE (IFU) PROVIDES THE FOLLOWING: 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 COMPLAINT DEVICE WAS FOUND TO HAVE A NON-FULLY FUNCTIONING BASKET DUE TO SHEATH DAMAGE. DEVICES ARE INSPECTED FOR DAMAGE AND FUNCTIONALITY PRIOR TO PACKAGING. THE CAUSE FOR THE OBSERVED ISSUE COULD NOT BE DETERMINED. MEASURES HAVE BEEN INITIATED TO ADDRESS THIS FAILURE MODE. 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.

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. (B)(4). PMA/510(K) #: EXEMPT. 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 THAT THE NGAGE NITINOL STONE EXTRACTOR WOULD NOT FULLY CLOSE DURING A URETEROSCOPY AND HAD TO USE ANOTHER EXTRACTOR TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268142 NGAGE NITINOL STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC 00827002482975

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR