BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR

    MDR report key: 19766983 · Received July 17, 2024

    Report

    Report Number
    1820334-2024-00971
    Event Type
    Malfunction
    Date Received
    July 17, 2024
    Date of Event
    July 5, 2024
    Report Date
    November 11, 2024
    Manufacturer
    COOK INC
    Product Code
    FFL
    UDI-DI
    10827002191102
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. E1: POSTAL CODE: (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

    ADDITIONAL INFORMATION: D9 CORRECTED INFORMATION: D4, H6: MEDICAL DEVICE PROBLEM CODE (ANNEX A), COMPONENT CODE (ANNEX G). DESCRIPTION OF EVENT: IT WAS REPORTED THE NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR'S BASKET WAS UNABLE TO BE CLOSED DURING A LEFT RENAL URETERAL LITHOTRIPSY AND LITHOTOMY PROCEDURE. THE DEVICE WAS TESTED PRIOR TO USE AND WAS ¿LIGHTLY STUCK¿ WHEN CLOSED. WHEN THE DEVICE WAS USED DURING THE PROCEDURE, IT WAS FOUND THE DEVICE WOULD NOT CLOSE. 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, AS WELL AS A VISUAL INSPECTION, AND FUNCTIONAL TEST OF THE RETURNED DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. ONE NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR WAS RETURNED AND THE BASKET WOULD NOT CLOSE DUE TO DAMAGE TO THE DISTAL END OF THE DEVICE. THE BASKET CANNULA THAT SECURED THE PROXIMAL ENDS OF THE BASKET WIRES WAS SEVERELY BENT. THE COIL ASSEMBLY WAS BENT AND THE HANDLE DID NOT ACTUATE THE BASKET FORMATION DUE TO THE BENT. SEVERAL KINKS IN THE BASKET SHEATH WERE OBSERVED. 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 NON-CONFORMANCES RELATED TO THE REPORTED FAILURE MODE. A REVIEW OF COMPLAINT HISTORY RECORDS SHOWS ONE OTHER COMPLAINT SIMILAR WITH THE COMPLAINT DEVICE LOT. BECAUSE THERE WERE NO RELATED NON-CONFORMANCES, ADEQUATE INSPECTION ACTIVITIES HAD BEEN ESTABLISHED, AND THERE WAS OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, IT WAS CONCLUDED THAT THERE WAS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. BASED ON THIS INFORMATION, THE DEVICE WAS MANUFACTURED TO SPECIFICATION. COOK ALSO REVIEWED PRODUCT LABELING. THE PRODUCT IFU, PROVIDES THE FOLLOWING INFORMATION TO THE USER: "PRECAUTION: DO NOT USE EXCESSIVE FORCE TO MANIPULATE THIS DEVICE. DAMAGE TO THE DEVICE MAY OCCUR." BASED ON THE INFORMATION PROVIDED, INSPECTION OF THE RETURNED DEVICE, AND THE RESULTS OF THE INVESTIGATION, THE CAUSE FOR THE DAMAGE 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 NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR'S BASKET WAS UNABLE TO BE CLOSED DURING A LEFT RENAL URETERAL LITHOTRIPSY AND LITHOTOMY PROCEDURE. THE DEVICE WAS TESTED PRIOR TO USE AND WAS ¿LIGHTLY STUCK¿ WHEN CLOSED. WHEN THE DEVICE WAS USED DURING THE PROCEDURE, IT WAS FOUND THE DEVICE WOULD NOT CLOSE. 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
    355355 NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC G19110 15744460 10827002191102

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male