BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NGAGE NITINOL STONE EXTRACTOR

    MDR report key: 19865372 · Received July 30, 2024

    Report

    Report Number
    1820334-2024-01029
    Event Type
    Malfunction
    Date Received
    July 30, 2024
    Date of Event
    July 23, 2024
    Report Date
    November 12, 2024
    Manufacturer
    COOK INC
    Product Code
    FFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: POSTAL CODE: 110092, PHONE:(B)(6), ADDITIONAL PHONE: (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.

    Additional Manufacturer Narrative · 0

    CORRECTIONS: D4: MODEL # = GPN #, H6: ANNEX A AND G. INVESTIGATION ¿ EVALUATION. IT WAS REPORTED THE 'NGAGE NITINOL STONE EXTRACTORS' BASKET CANNOT BE OPENED PRIOR TO AN UNSPECIFIED PROCEDURE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-LIKE DEVICE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES 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. INTERVIEW OF PERSONNEL WAS ALSO CONDUCTED. FUNCTIONAL TESTS AND VISUAL INSPECTION OF THE RETURNED COMPLAINT DEVICE WAS ALSO CONDUCTED. ONE DEVICE WAS RETURNED FOR INVESTIGATION IN AN OPEN PACKAGE WITH LABEL. UPON INSPECTION NO SIGNIFICANT DAMAGE TO THE DEVICE WAS NOTICED. HANDLE WAS ACTUATED, AND THE BASKET WOULD NOT OPEN/CLOSE. SUPPORT TUBING WAS DETACHED FROM THE BASKET SHEATH. GLUE IS PRESENT ON THE BASKET SHEATH. 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 FIVE RELATED NON-CONFORMANCES REPORTED FOR LOT. THE NON-CONFORMANCE RELATED TO LACK LOSS OFF FUNCTION ARE SIMILAR TO THE REPORTED FAILURE MODE. ALL DEVICES ARE INSPECTED FOR FUNCTIONALITY AND DAMAGE DURING MANUFACTURING AND QUALITY CONTROL CHECKS AND THE COMPLAINT DEVICES PASSED THOSE INSPECTIONS. THE NON-CONFORMING PRODUCT WAS SCRAPPED PRIOR TO LOT RELEASE. A COMPLAINT HISTORY DATABASE SEARCH SHOWED NO OTHER RELATED COMPLAINTS ASSOCIATED WITH THE FAILURE MODE FOR THE COMPLAINT DEVICE LOT. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE NGAGE NITINOL STONE EXTRACTOR'S BASKET CANNOT BE OPENED PRIOR TO AN UNSPECIFIED PROCEDURE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-LIKE DEVICE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES 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
    240027 NGAGE NITINOL STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC G48297 15840332

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male