BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NGAGE NITINOL STONE EXTRACTOR

    MDR report key: 20684752 · Received November 14, 2024

    Report

    Report Number
    1820334-2024-01485
    Event Type
    Malfunction
    Date Received
    November 14, 2024
    Report Date
    January 13, 2025
    Manufacturer
    COOK INC
    Product Code
    FFL
    UDI-DI
    10827002482958
    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, UNAVAILABLE, OR UNCHANGED. CORRECTED INFORMATION: H6: MEDICAL DEVICE PROBLEM CODE (ANNEX A), COMPONENT CODE (ANNEX G). INVESTIGATION EVALUATION: DESCRIPTION OF EVENT: AS REPORTED, THE USER CHECKED THE BASKET OF AN NGAGE NITINOL STONE EXTRACTOR PRIOR TO PATIENT CONTACT DURING A KIDNEY STONE REMOVAL PROCEDURE AND FOUND OUT THE BASKET TIP WIRE WAS ABNORMAL. THE BASKET COULD NOT BE OPENED OR CLOSED PROPERLY. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-LIKE DEVICE. A PHOTO WAS PROVIDED OF WHAT APPEARS TO SHOW A BROKEN BASKET WIRE. 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, AND A VISUAL INSPECTION OF THE RETURNED DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. ONE NGAGE NITINOL STONE EXTRACTOR WAS RETURNED IN OPENED PACKAGE WITH LABEL. HANDLE IN CLOSED POSITION. HANDLE DOES NOT ACTUATE BASKET FORMATION. SHRINK WRAP ON ONE SECTION OF FORMATION IS TORN LOOSE. HANDLE DISASSEMBLED, DOES NOT MANUALLY ACTUATE FORMATION. THE RETURNED DEVICE WAS FOUND TO BE DAMAGED. THE TUBING THAT SURROUNDS THE BASKET WIRES, HOLDS THEM IN PLACE, AND CREATES THE PROPER SHAPE WERE SPLIT. THE PROVIDED INFORMATION STATED THE ISSUE OCCURRED BEFORE USE OF THE DEVICE. 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 RELATED COMPLAINTS ASSOCIATED WITH 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 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: IMPORTANT: EXCESSIVE FORCE COULD DAMAGE DEVICE. COOK HAS CONCLUDED THAT THE CAUSE FOR THE COMPLAINT COULD NOT BE ESTABLISHED. 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.

    Additional Manufacturer Narrative · 0

    E1 - NAME AND ADDRESS: STREET ADDRESS: (B)(6). 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

    AS REPORTED, THE USER CHECKED THE BASKET OF AN NGAGE NITINOL STONE EXTRACTOR PRIOR TO PATIENT CONTACT DURING A KIDNEY STONE REMOVAL PROCEDURE AND FOUND OUT THE BASKET TIP WIRE WAS ABNORMAL. THE BASKET COULD NOT BE OPENED OR CLOSED PROPERLY. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-LIKE DEVICE. A PHOTO WAS PROVIDED THAT APPEARS TO SHOW A BROKEN BASKET WIRE. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1196503 NGAGE NITINOL STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC G48295 15843382 10827002482958

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male