BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NCIRCLE TIPLESS STONE EXTRACTOR

    MDR report key: 19651271 · Received July 1, 2024

    Report

    Report Number
    1820334-2024-00890
    Event Type
    Malfunction
    Date Received
    July 1, 2024
    Date of Event
    June 18, 2024
    Report Date
    October 21, 2024
    Manufacturer
    COOK INC
    Product Code
    FFL
    UDI-DI
    10827002187785
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. 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

    INVESTIGATION EVALUATION: DESCRIPTION OF EVENT: IT WAS REPORTED THE NCIRCLE TIPLESS STONE EXTRACTOR WAS UNABLE TO OPEN THE BASKET WOULD NOT OPEN AND CLOSE UPON OPENING OF THE PACKAGE, DURING AN URETEROSCOPY PROCEDURE. THE DEVICE WAS TESTED PRIOR TO USE WITH NO ISSUES, USED ONE TIME OPEN AND CLOSED, THEN AFTERWARDS IT WOULD NOT DEPLOY. 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), MANUFACTURING INSTRUCTIONS (MI), AND QUALITY CONTROL (QC) PROCEDURES, A VISUAL INSPECTION, AND FUNCTIONAL TEST OF THE RETURNED DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. ONE NCIRCLE TIPLESS STONE EXTRACTOR RETURNED FOR INVESTIGATION, IN OPENED PACKAGING. THE HANDLE IN OPEN POSITION. COLLETT AND MLLA TIGHT. PETT PRESENT. HANDLE MOVES FREELY BUT DOES NOT ACTUATE BASKET FORMATION. HANDLE DISASSEMBLED, SUPPORT SHEATH IS LOOSE FROM BASKET SHEATH. 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) WAS PERFORMED AND RELATED NONCONFORMANCE'S WERE IDENTIFIED AND SCRAPPED PRIOR TO DISTRIBUTION. THEREFORE, IT IS UNLIKELY THIS ISSUE AFFECTS THE ENTIRE LOT. A REVIEW OF COMPLAINT HISTORY RECORDS SHOWS NO OTHER COMPLAINTS ASSOCIATED WITH THE COMPLAINT DEVICE LOT. THE INFORMATION PROVIDED UPON REVIEW OF COMPLAINT FILE, DEVICE HISTORY RECORD, COMPLAINT HISTORY, AND QUALITY CONTROL DOCUMENTS DID NOT PROVIDE EVIDENCE TO SUPPORT THAT THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION OR TO SUGGEST ITEMS IN THE LOT OR SIMILAR DEVICES IN THE FIELD OR IN HOUSE WERE NONCONFORMING. COOK ALSO REVIEWED PRODUCT LABELING. THE PRODUCT IFU, DID NOT PROVIDE ANY INFORMATION RELATED TO THE REPORTED ISSUE. ONE BASKET WAS RETURNED. EXAMINATION REVEALED THE SUPPORT SHEATH SEPARATED FROM THE STRAIN RELIEF PREVENTING THE HANDLE FROM ACTUATING THE BASKET. A DEFINITIVE CAUSE COULD NOT BE ESTABLISHED AT THIS TIME. 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 NCIRCLE TIPLESS STONE EXTRACTOR WAS UNABLE TO OPEN DURING A URETEROSCOPY PROCEDURE. THE DEVICE WAS AS ABLE TO OPEN AND CLOSE ONCE, THEN WAS UNABLE TO OPEN A SECOND TIME. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-LIKE DEVICE. THE DEVICE WAS TESTED PRIOR TO USE AND WAS ABLE TO FUNCTION. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS UNAVAILABLE AT THIS TIME.

    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
    616138 NCIRCLE TIPLESS STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC G18778 15926835 10827002187785

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown