BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NCIRCLE TIPLESS STONE EXTRACTOR

    MDR report key: 17455439 · Received August 3, 2023

    Report

    Report Number
    1820334-2023-01022
    Event Type
    Malfunction
    Date Received
    August 3, 2023
    Date of Event
    July 21, 2023
    Report Date
    October 23, 2023
    Manufacturer
    COOK INC
    Product Code
    FFL
    UDI-DI
    10827002175201
    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, UNAVAILABLE, OR UNCHANGED. CORRECTION: H6 COMPONENT CODE (ANNEX G). EVENT SUMMARY A REPRESENTATIVE OF XIAN KANGWEI MEDICAL EQUIPMENT CO., LTD INFORMED COOK ON 26JUL2023 OF AN INCIDENT INVOLVING A NCIRCLE TIPLESS STONE EXTRACTOR (RPN: NTSE-045065-UDH) FROM LOT # 15235012. IT WAS REPORTED THAT THE BASKET COULD NOT BE OPENED PRIOR TO A BLADDER STONE REMOVAL PROCEDURE ON (B)(6) 2023. 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 NCIRCLE TIPLESS STONE EXTRACTOR WAS RETURNED TO COOK FOR EVALUATION IN OPEN ORIGINAL PACKAGE. DURING A VISUAL EXAM IT WAS FOUND THE CATHETER IS CURVED 3 CM FROM THE HANDLE, AND THE DISTAL TIP OF CATHETER IS SMASHED. A FUNCTIONAL TEST FOUND THE HANDLE DOES NOT ACTUATE BASKET FORMATION. THE HANDLE WAS DISASSEMBLED, AND THE CANNULATED HANDLE AND COIL ASSEMBLY WERE FOUND SEVERED. 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 DHR FOR THE REPORTED COMPLAINT DEVICE LOT, 15235012, REVEALED NO RECORDED NON-CONFORMANCES RELEVANT TO THE FAILURE MODE. A DATABASE SEARCH DID NOT IDENTIFY ANY OTHER COMPLAINTS ASSOCIATED WITH THE REPORTED 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 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 COULD NOT BE CONCLUSIVELY DETERMINED. THE BROKEN BASKET ASSEMBLY INDICATES THE DEVICE MAY HAVE BEEN EXPOSED TO A LARGE TENSILE FORCE, BUT THERE WAS NO INFORMATION KNOWN RELATED TO FORCES APPLIED TO THE DEVICE. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE 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.

    Additional Manufacturer Narrative · 0

    E1: (B)(6). E3: OCCUPATION: AGENT. 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.

    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

    IT WAS REPORTED, PRIOR TO A BLADDER STONE REMOVAL PROCEDURE, THE BASKET OF A 'NCIRCLE TIPLESS STONE EXTRACTOR' WOULD NOT OPEN PROPERLY. THE ISSUE WAS NOTICED WHEN THE DEVICE WAS REMOVED FROM THE PACKAGING. THE USER CHANGED TO A SAME TYPE DEVICE TO COMPLETE THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1480967 NCIRCLE TIPLESS STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC 15235012 10827002175201

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male