BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NGAGE NITINOL STONE EXTRACTOR

    MDR report key: 20157457 · Received September 6, 2024

    Report

    Report Number
    1820334-2024-01188
    Event Type
    Malfunction
    Date Received
    September 6, 2024
    Date of Event
    August 21, 2024
    Report Date
    December 3, 2024
    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

    INVESTIGATION ¿ EVALUATION. IT WAS REPORTED, THE USER DETECTED THE BASKET OF AN NGAGE NITINOL STONE EXTRACTOR CANNOT BE OPENED OR CLOSED PROPERLY DURING AN UNSPECIFIED PROCEDURE, THEN THE USER CHANGED TO A NEW ONE TO CONTINUE 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. REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), MANUFACTURER¿S INSTRUCTIONS (MI), AND QUALITY CONTROL (QC) PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. FUNCTIONAL TESTS AND VISUAL INSPECTION OF THE RETURNED COMPLAINT DEVICE WAS ALSO CONDUCTED. ONE NGAGE NITINOL STONE EXTRACTOR WAS RETURNED FOR INVESTIGATION IN AN OPEN PACKAGE WITH LABEL. THE HANDLE WILL ACTUATE BASKET, NO DAMAGE TO THE DEVICE IS VISIBLE, UNABLE TO REPEAT THE REPORTED ISSUE. COOK HAS CONCLUDED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. 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 RELATED NON-CONFORMANCES REPORTED TO THIS INCIDENT. A COMPLAINT HISTORY DATABASE SEARCH SHOWED NO OTHER RELATED COMPLAINTS ASSOCIATED WITH THE FAILURE MODE FOR 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 THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE IFU SUPPLIED WITH THE DEVICE DID NOT PROVIDE ANY INFORMATION RELATED TO THE REPORTED ISSUE. BASED UPON THE AVAILABLE INFORMATION, INSPECTION OF THE RETURNED DEVICE, AND RESULTS OF THE INVESTIGATION, 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

    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, THE USER DETECTED THE BASKET OF AN NGAGE NITINOL STONE EXTRACTOR CANNOT BE OPENED OR CLOSED PROPERLY DURING AN UNSPECIFIED PROCEDURE, THEN THE USER CHANGED TO A NEW ONE TO CONTINUE 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
    2139527 NGAGE NITINOL STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC G48295 15434679 10827002482958

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown