BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NGAGE NITINOL STONE EXTRACTOR

    MDR report key: 19029145 · Received April 2, 2024

    Report

    Report Number
    1820334-2024-00458
    Event Type
    Malfunction
    Date Received
    April 2, 2024
    Date of Event
    March 8, 2024
    Report Date
    September 27, 2024
    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

    G4: PMA/510K #: 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.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION: D4. H6: MEDICAL DEVICE PROBLEM (ANNEX A). COMPONENT CODE (ANNEX G). INVESTIGATION EVALUATION: DESCRIPTION OF EVENT: AS REPORTED, DURING A FLEXIBLE URETEROSCOPY, THE USER SUCCESSFULLY REMOVED ONE STONE WITH AN NGAGE NITINOL STONE EXTRACTOR, AND THE BASKET WOULD NO LONGER FUNCTION. ANOTHER SAME TYPE OF DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE COMPLAINANT HAS NOT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE. REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS (MI), AND QUALITY CONTROL (QC) PROCEDURES, AS WELL AS INTERVIEW PERSONNEL, A VISUAL INSPECTION, AND FUNCTIONAL TEST OF THE RETURNED DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. ONE NGAGE NITINOL STONE EXTRACTOR, WAS RETURNED IN AN OPEN PACKAGE WITH LABEL. WIRES OF BASKET WERE BROKEN WITH A CHARRED APPEARANCE. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) 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 ARE 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 THE IFU PROVIDES THE FOLLOWING INFORMATION: SUGGESTED HANDLING INSTRUCTIONS FOR EXTRACTORS AND FORCEPS: CAUTION: THIS DEVICE IS CONDUCTIVE. AVOID CONTACT WITH ANY ELECTRIFIED INSTRUMENT. THE RETURNED DEVICE WAS FOUND TO HAVE TWO BROKEN BASKET WIRES. THE ENDS OF THE WIRES HAD A CHARRED APPEARANCE, INDICATING EXPOSURE TO A LASER OR OTHER ELECTRIFIED INSTRUMENT. THE IFU SUPPLIED WITH THE DEVICE STATES "CAUTION: THIS DEVICE IS CONDUCTIVE. AVOID CONTACT WITH ANY ELECTRIFIED INSTRUMENT. ". THE LIKELY CAUSE FOR THE ISSUE WAS AN INADVERTENT USER ERROR. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND COOK WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, 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

    AS REPORTED, DURING A FLEXIBLE URETEROSCOPY, THE USER SUCCESSFULLY REMOVED ONE STONE WITH AN NGAGE NITINOL STONE EXTRACTOR, AND THE BASKET WOULD NO LONGER FUNCTION. ANOTHER SAME TYPE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE COMPLAINANT HAS NOT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1607468 NGAGE NITINOL STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC G48294 15653722 10827002482941

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Male