BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NGAGE NITINOL STONE EXTRACTOR

    MDR report key: 17494342 · Received August 9, 2023

    Report

    Report Number
    1820334-2023-01055
    Event Type
    Malfunction
    Date Received
    August 9, 2023
    Date of Event
    July 26, 2023
    Report Date
    November 1, 2023
    Manufacturer
    COOK INC
    Product Code
    FFL
    UDI-DI
    10827002482941
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. CORRECTED INFORMATION: H6: COMPONENT CODE (ANNEX G) AND MEDICAL DEVICE PROBLEM CODE (ANNEX A). EVENT DESCRIPTION: IT WAS REPORTED THAT AFTER A LITHOTRIPSY PROCEDURE, THE USER FOUND THAT THE WIRE WAS BROKEN ON THE BASKET OF AN NGAGE NITINOL STONE EXTRACTOR. THE USER CHANGED TO ANOTHER SAME TYPE DEVICE TO COMPLETE THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. 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, DEVICE HISTORY RECORD (DHR), MANUFACTURING INSTRUCTIONS, THE INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL PROCEDURES. ONE NGAGE NITINOL STONE EXTRACTOR WAS RETURNED INSIDE ITS MARKETING BOX. INSPECTION OF THE RETURNED DEVICE NOTED: THE BASKET SHEATH WAS BENT/KINKED AT THE SUPPORT SHEATH. THERE WERE NO BROKEN WIRES VISIBLE, THE BASKET FORMATION WAS INTACT. THE BASKET OPENED AND CLOSED WHEN THE HANDLE WAS FUNCTIONED. BASKET FORMATION WAS SLIGHTLY ASYMMETRICAL. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE MODE. A REVIEW OF COMPLAINT HISTORY RECORDS SHOWS NO OTHER COMPLAINTS ASSOCIATED WITH THE COMPLAINT DEVICE LOT. BECAUSE THERE WERE NO RELATED NON-CONFORMANCES, ADEQUATE INSPECTION ACTIVITIES HAVE BEEN ESTABLISHED, THERE IS OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, AND NO OTHER LOT RELATED COMPLAINTS THAT HAVE BEEN RECEIVED FROM THE FIELD, IT WAS CONCLUDED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION AND THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN THE FIELD. A REVIEW OF RELEVANT MANUFACTURING AND QUALITY CONTROL DOCUMENTS WAS CONDUCTED. ALL EXTRACTORS ARE VERIFIED TO ASSURE THE BASKET OPENS AND CLOSES PROPERLY. COOK HAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE INSTRUCTIONS FOR USE (IFU) DOES NOT PROVIDE ANY INFORMATION RELATED TO THE REPORTED ISSUE THE RETURNED DEVICE WAS FOUND TO HAVE ALL BASKET WIRES INTACT. SLIGHT DAMAGE TO THE BASKET WIRE SHEATHS WAS OBSERVED, WHICH CAUSED THE BASKET TO BE SLIGHTLY MISSHAPED. A LIKELY CAUSE FOR THE ISSUE COULD NOT BE DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. THE APPROPRIATE 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.

    Additional Manufacturer Narrative · 0

    G4 ¿ 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. 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

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A LITHOTRIPSY PROCEDURE, THE USER FOUND THAT THE WIRE WAS BROKEN ON THE BASKET OF AN NGAGE NITINOL STONE EXTRACTOR. THE USER CHANGED TO ANOTHER SAME TYPE DEVICE TO COMPLETE THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1684530 NGAGE NITINOL STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC N/A 15196703 10827002482941

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown