BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NCIRCLE TIPLESS STONE EXTRACTOR

    MDR report key: 9558668 · Received January 7, 2020

    Report

    Report Number
    1820334-2020-00072
    Event Type
    Malfunction
    Date Received
    January 7, 2020
    Date of Event
    December 17, 2019
    Report Date
    February 28, 2020
    Manufacturer
    COOK INC
    Product Code
    FFL
    UDI-DI
    10827002462066
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION: CALVARY HEALTH CARE ST VINCENTS INFORMED COOK ON 12/19/2019 OF AN INCIDENT INVOLVING A NCIRCLE TIPLESS STONE EXTRACTOR NTSE-015115 FROM LOT # 9945378. THE BASKET OF THE DEVICE REPORTEDLY BROKE WITHIN THE FIRST 4 USES DURING A URETEROSCOPY PROCEDURE ON (B)(6) 2019. THE PATIENT REPORTEDLY EXPERIENCED NO ADDITIONAL HARM AS A RESULT OF THE ISSUE. A DOCUMENT BASED INVESTIGATION WAS PERFORMED INCLUDING A REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORD, THE INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL DATA. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE THAT THIS DEVICE WAS MADE OUT OF SPECIFICATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE MODE. A REVIEW OF COMPLAINT HISTORY RECORDS SHOWS NO OTHER COMPLAINTS ASSOCIATED WITH THE COMPLAINT DEVICE LOT. BECAUSE THERE ARE NO RELATED NON-CONFORMANCES, ADEQUATE INSPECTION ACTIVITIES HAVE BEEN ESTABLISHED, THERE IS OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, AND NO OTHER LOT RELATED COMPLAINTS THAT HAVE BEEN RECEIVED FROM THE FIELD, IT WAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. THE INSTRUCTIONS FOR USE (IFU), PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: 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. A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS WAS CONDUCTED. IT WAS CONCLUDED THAT THE DEVICE ASPECT IN QUESTION WAS VISUALLY/FUNCTIONALLY INSPECTED BY QUALITY CONTROL AND NO RELATED GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE NOTED. NO PRODUCT WAS RETURNED. NO PHOTOS WERE PROVIDED. A SEARCH OF THE NORTH AMERICAN DISTRIBUTION CENTER (NADC) DATABASE FOUND ALL DEVICES FROM LOT 9945378 HAVE BEEN SHIPPED. THEREFORE, NO SIMILAR PRODUCT FROM THE SAME LOT IS AVAILABLE FOR INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED. THE INFORMATION PROVIDED STATED THAT THE DEVICE BROKE WITHIN 4 USES. IT WAS ASSUMED THAT "BROKE" MEANT THAT THE BASKET OF THE DEVICE WOULD NOT OPEN/CLOSE PROPERLY, AS THAT IS THE MOST COMMON FAILURE MODE FOR THE NTSE EXTRACTOR. WITHOUT THE DEVICE AVAILABLE FOR INVESTIGATION, THE CAUSE FOR THE COMPLAINT COULD NOT BE DETERMINED. THERE ARE MULTIPLE POSSIBLE CAUSES FOR THE FAILURE OF THE BASKET TO FUNCTION PROPERLY: THE SIZE, SHAPE, LOCATION OF THE STONE COULD HAVE CAUSED STRESS TO THE DEVICE THAT RESULTED IN DAMAGE. THE DEVICE COULD HAVE BEEN DAMAGED FROM HANDLING. A MANUFACTURING ISSUE COULD HAVE PREVENTED THE BASKET FROM FUNCTIONING. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. COOK MEDICAL HAS NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS. 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 PATIENT OR EVENT INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER: NAME AND ADDRESS: POSTAL CODE: (B)(6). PMA/510K # ¿ EXEMPT. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED, DURING A URETEROSCOPY, A STONE LOCATED IN THE KIDNEY WAS BROKEN UP WITH A LASER. AN NCIRCLE TIPLESS STONE EXTRACTOR WAS USED TO REMOVE THE STONE FRAGMENTS. THE BASKET "BROKE" WITHIN FOUR USES.(REFERENCE PATIENT IDENTIFIER (B)(6)) A SECOND NCIRCLE TIPLESS STONE EXTRACTOR FROM A DIFFERENT LOT NUMBER WAS OPENED AND THE BASKET "BROKE" WITHIN 4 USES. (THIS MDR IS FOR THE SECOND DEVICE.). IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE PATIENT AND THE EVENT. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22336 NCIRCLE TIPLESS STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC 9945378 10827002462066

    Patients

    Seq Age Sex Outcome Treatment
    1