BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR

    MDR report key: 7429939 · Received April 13, 2018

    Report

    Report Number
    1820334-2018-00965
    Event Type
    Malfunction
    Date Received
    April 13, 2018
    Date of Event
    April 4, 2018
    Report Date
    May 3, 2018
    Manufacturer
    COOK INC
    Product Code
    FFL
    UDI-DI
    00827002191105
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION: THE NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR WAS NOT RETURNED FOR EVALUATION AND NO PHOTOGRAPHS WERE PROVIDED. WITHOUT THE COMPLAINT DEVICE, A PHYSICAL INVESTIGATION WAS NOT ABLE TO BE COMPLETED. A DOCUMENT BASED INVESTIGATION WAS PERFORMED. A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE, QUALITY CONTROL DATA AND SPECIFICATIONS WAS CONDUCTED. THE DEVICE HISTORY RECORD WAS REVIEWED. THERE WERE NO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE. A REVIEW OF COMPLAINT HISTORY REVEALED THIS COMPLAINT IS THE ONLY ONE ASSOCIATED WITH LOT NUMBER 8172201. CURRENT CONTROLS ARE IN PLACE IN MANUFACTURING TO ASSURE DEVICE FUNCTIONALITY PRIOR TO SHIPPING. REVIEW OF PRODUCTION AND QUALITY DOCUMENTATION DID NOT OBSERVE ANY SPECIFIC ISSUES WITH CURRENT MANUFACTURING OR QUALITY CONTROLS THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT. THERE IS NO INDICATION THAT A DESIGN OR PROCESS RELATED FAILURE MODE CONTRIBUTED TO THIS EVENT. AS PER THE INSTRUCTIONS FOR USE (IFU): DO NOT USE EXCESSIVE FORCE TO MANIPULATE THIS DEVICE. DAMAGE TO THE DEVICE MAY OCCUR. WITH THE INFORMATION AVAILABLE, THE CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR HAD BEEN USED SEVERAL TIMES AND THE FORTH OR FIFTH TIME, THE BASKET WOULD NOT FULLY CLOSE AND THE USER HAD DIFFICULTY REMOVING STONES DURING A URETEROSCOPY. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE DEVICE IN QUESTION. A SECTION OF THE DEVICE DID NOT REMAIN 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 OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271383 NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC 00827002191105

    Patients

    Seq Age Sex Outcome Treatment
    1