BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NCIRCLE TIPLESS STONE EXTRACTOR

    MDR report key: 17424990 · Received July 31, 2023

    Report

    Report Number
    1820334-2023-00985
    Event Type
    Malfunction
    Date Received
    July 31, 2023
    Date of Event
    July 12, 2023
    Report Date
    November 2, 2023
    Manufacturer
    COOK INC
    Product Code
    FFL
    UDI-DI
    10827002187785
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT SUMMARY: A REPRESENTATIVE OF URUMQI SONGAN MEDICAL DEVICES CO., LTD (CHINA) INFORMED COOK ON 12JUL2023 OF AN INCIDENT INVOLVING A NCIRCLE TIPLESS STONE EXTRACTOR (RPN: NTSE-022115-UDH) FROM LOT #15076383. IT WAS REPORTED THAT TWO BASKETS DID NOT OPEN AND CLOSE PROPERLY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT REPORTEDLY EXPERIENCED NO HARM AS A RESULT OF THE ISSUE. INVESTIGATION ¿ EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS (MI), AND QUALITY CONTROL PROCEDURES, AS WELL AS A VISUAL INSPECTION AND FUNCTIONAL TEST OF THE RETURNED DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. ONE DEVICE WAS RETURNED TO COOK FOR EVALUATION IN AN OPEN POUCH WITH SHIPPING TRAY. THE BASKET COULD NOT BE OPENED OR CLOSED. THE YELLOW SUPPORT SHEATH WAS KINKED AND SPLIT APPROXIMATELY 1CM FROM THE HANDLE. 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 DHRS FOR THE REPORTED COMPLAINT DEVICE LOT REVEALED ONE RELATED NON-CONFORMANCE FOR ¿GLUE, INADEQUATE" IN WHICH ONE DEVICE WAS SCRAPPED. A LOT HISTORY SEARCH FOUND 14 OTHER COMPLAINTS HAD BEEN REPORTED FOR THIS LOT, ALL FOR SIMILAR ISSUES. CONTAINMENT ACTIVITIES AND FIELD ACTION ASSESSMENT WERE PERFORMED FOR THE DEVICE LOT AND IT WAS DETERMINED THAT NO FIELD ACTION WAS NECESSARY. ADDITIONALLY, THE HEALTH HAZARD EVALUATION FOR THIS ISSUE DETERMINED THE ASSOCIATED RISK TO BE LOW. AS SUCH, A HEIGHTENED PATIENT RISK IS NOT EXPECTED TO OCCUR. COOK ALSO REVIEWED PRODUCT LABELING. THE PRODUCT IFU, T _ NTSE_ REV1; THE 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 DAMAGE COULD NOT BE DETERMINED. 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

    E1: CUSTOMER NAME AND ADDRESS = (B)(6). G4: 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, AN NCIRCLE TIPLESS STONE EXTRACTOR WAS TESTED PRIOR TO USE AND COULD NOT BE OPENED OR CLOSED PROPERLY WHILE ACTUATING THE HANDLE. ANOTHER BASKET WITH THE SAME LOT NUMBER WAS TESTED TO CONTINUE THE PROCEDURE AND IT WAS FOUND THAT THE BASKET WOULD NOT OPEN. A THIRD LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION AND DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637296 NCIRCLE TIPLESS STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC 15076383 10827002187785

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown