BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NCIRCLE TIPLESS STONE EXTRACTOR

    MDR report key: 16639642 · Received March 29, 2023

    Report

    Report Number
    1820334-2023-00342
    Event Type
    Malfunction
    Date Received
    March 29, 2023
    Date of Event
    March 15, 2023
    Report Date
    June 7, 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

    EVENT SUMMARY: IT WAS REPORTED THAT THE DISTAL END OF A NCIRCLE TIPLESS STONE EXTRACTOR BASKET COULD NOT BE OPENED OR CLOSED. THE ISSUE WAS FOUND PRIOR TO PATIENT CONTACT. ANOTHER DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS. 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), AND QUALITY CONTROL PROCEDURES, AS WELL AS A VISUAL INSPECTION AND FUNCTIONAL TEST OF THE DEVICE WERE CONDUCTED. THE DEVICE WAS RETURNED IN AN OPENED PACKAGING TO COOK FOR INVESTIGATION. HANDLE WAS RETURNED IN OPEN POSITION, WITH BASKET ASSEMBLY OPEN. CANNULATED HANDLE WAS NOT HELD SECURELY IN COLLETT. THE RED FITTING FROM PRODUCT PROTECTOR WAS STILL ASSEMBLED ON MLLA (MALE LUER LOCK ADAPTER). THE SUPPORT SHEATH IS DAMAGED BENEATH THE RED FITTING. THE HANDLE WAS DISASSEMBLED; BLACK SHAVINGS WERE REMOVED FROM BRASS FITTING. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. NO RELATED NON-CONFORMANCES WERE RECORDED. NO ADDITIONAL COMPLAINTS WERE RECEIVED FOR THIS PRODUCT LOT. THE DEVICE HISTORY RECORD REVIEW PROVIDES OBJECTIVE EVIDENCE THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE OF NONCONFORMING DEVICES FROM THE COMPLAINT LOT IN HOUSE OR IN THE FIELD. A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS WAS CONDUCTED. IT WAS CONCLUDED THAT THE DEVICE ASPECT IN QUESTION WAS FUNCTIONALLY INSPECTED BY QUALITY CONTROL AND NO NOTABLE GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE NOTED. THERE IS NO INDICATION THAT A DESIGN OR PROCESS RELATED FAILURE MODE CONTRIBUTED TO THE REPORTED EVENT. SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. COOK ALSO REVIEWED PRODUCT LABELING. THE PRODUCT IFU, T _ NTSE_ REV1, PROVIDES THE FOLLOWING INFORMATION TO THE USER: PRECAUTION: THE DEVICE IS CONDUCTIVE. AVOID CONTACT WITH ANY ELECTRIFIED INSTRUMENT. PRECAUTION: ENCLOSE THE DEVICE IN THE SHEATH BEFORE REMOVING FROM THE TRAY/HOLDER. PRECAUTION: DO NOT USE EXCESSIVE FORCE TO MANIPULATE THIS DEVICE. DAMAGE TO THE DEVICE MAY OCCUR BASED ON THE AVAILABLE INFORMATION, COOK HAS CONCLUDED THE CAUSE FOR THE SEPARATION OF THE CANNULATED HANDLE AND COLLET COULD NOT BE DETERMINED. IT WAS LIKELY THE SEPARATION OF THE CANNULATED HANDLE AND COLLET WAS THE CAUSE OF THE ISSUE AS THE BASKET SHEATH DAMAGE WAS NOT SIGNIFICANT. 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

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. INITIAL REPORTER: CUSTOMER ADDRESS = (B)(6). PHONE = (B)(6). INITIAL REPORTER: CUSTOMER OCCUPATION = UNKNOWN. 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

    ADDITIONAL INFORMATION RECEIVED 15MAY2023: ANOTHER DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DISTAL END OF A NCIRCLE TIPLESS STONE EXTRACTOR BASKET COULD NOT BE OPENED OR CLOSED. THE ISSUE WAS FOUND PRIOR TO PATIENT CONTACT. ADDITIONAL INFORMATION REGARDING EVENT DETAILS, PATIENT ANATOMY AND OUTCOME HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565932 NCIRCLE TIPLESS STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC 14602797 10827002175201

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown