BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NGAGE NITINOL STONE EXTRACTOR

    MDR report key: 16618621 · Received March 27, 2023

    Report

    Report Number
    1820334-2023-00315
    Event Type
    Malfunction
    Date Received
    March 27, 2023
    Date of Event
    March 13, 2023
    Report Date
    June 20, 2023
    Manufacturer
    COOK INC
    Product Code
    FFL
    UDI-DI
    10827002482972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT SUMMARY AS REPORTED, DURING TESTING OF AN NGAGE NITINOL STONE EXTRACTOR, WHEN THE PROXIMAL END OF THE DEVICE IS CURVED, THE BASKET DOES NOT OPEN SMOOTHLY, IT IS DIFFICULT TO OPEN AND CLOSE THE BASKET. THERE WAS NO PATIENT INVOLVEMENT. INVESTIGATION ¿ EVALUATION A DOCUMENT BASED INVESTIGATION WAS PERFORMED INCLUDING A REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS (MI), QUALITY CONTROL PROCEDURES, AS WELL AS A VISUAL INSPECTION AND FUNCTIONAL TEST OF THE RETURNED DEVICE WERE CONDUCTED. ONE DEVICE WAS RETURNED TO COOK WITHOUT PACKAGE AND A COPY OF THE LABEL FOR EVALUATION. UPON INSPECTION THERE WASN'T ANY NOTICEABLE DAMAGE TO THE DEVICE. WHEN THE HANDLE WAS ACTUATED, THE BASKET WOULD NOT FUNCTION PROPERLY. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DHRS FOR THE REPORTED COMPLAINT DEVICE LOT SHOWED ONE RELATED NON-CONFORMANCE FOR ¿BASKET/GRASPER WILL NOT OPEN/CLOSE¿ IN WHICH SEVENTEEN DEVICES WERE SCRAPPED A LOT HISTORY SEARCH FOUND NO OTHER COMPLAINTS HAD BEEN REPORTED FOR THIS LOT. THE DEVICE LOT WAS MANUFACTURED (B)(6) 2023. AN INCREASE IN COMPLAINTS FOR THE NGE 2.2 FR SIZED DEVICE OCCURRED WITH DEVICES MANUFACTURED FROM LATE DECEMBER TO EARLY JANUARY. THE PRODUCT SPECIFICATION FOR THE NGAGE NITINOL STONE EXTRACTOR NGE-022115-MB WAS REVIEWED, AND 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. COOK ALSO REVIEWED PRODUCT LABELING. THE PRODUCT IFU DID NOT PROVIDE ANY INFORMATION RELATED TO THE REPORTED ISSUE. BASED ON THE INFORMATION PROVIDED, INSPECTION OF THE RETURNED DEVICE, AND THE RESULTS OF THE INVESTIGATION, THE CAUSE FOR THE ISSUE HAD NOT YET BEEN DETERMINED. THE ISSUE WAS IDENTIFIED AS BEING WITH THE BASKET ASSEMBLY, WHICH IS A SUPPLIED COMPONENT. A SUPPLIER CORRECTIVE ACTION REQUEST WAS CREATED TO ADDRESS THE ISSUE. COOK WILL CONTINUE MONITORING OF SIMILAR COMPLAINTS AND HAS NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. ¿ PER A REVIEW OF RISK DOCUMENTATION, 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

    INITIAL REPORTER NAME AND ADDRESS: POSTAL CODE: (B)(6). PMA/510(K) NUMBER = 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 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

    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, DURING TESTING OF AN NGAGE NITINOL STONE EXTRACTOR, WHEN THE PROXIMAL END OF OF THE DEVICE IS CURVED, THE BASKET DOES NOT OPEN SMOOTHLY, IT IS DIFFICULT TO OPEN AND CLOSE THE BASKET. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836371 NGAGE NITINOL STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC 15200485 10827002482972

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown