BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NCIRCLE TIPLESS STONE EXTRACTOR

    MDR report key: 7582312 · Received June 8, 2018

    Report

    Report Number
    1820334-2018-01685
    Event Type
    Malfunction
    Date Received
    June 8, 2018
    Date of Event
    February 23, 2018
    Report Date
    July 26, 2018
    Manufacturer
    COOK INC
    Product Code
    FFL
    UDI-DI
    00827002187788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CONCLUSION CODES ¿ (B)(4), CAUSE NOT ESTABLISHED. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION. THE DEVICE WAS NOT RETURNED FOR AN EVALUATION AND NO PHOTOGRAPHS WERE PROVIDED. WITHOUT THE COMPLAINT DEVICE, A PHYSICAL INVESTIGATION WAS NOT ABLE TO BE COMPLETED. A SEARCH OF THE NORTH AMERICAN DISTRIBUTION CENTER DATABASE SHOWS THAT ALL DEVICES FROM LOT 7944524 HAVE BEEN SHIPPED. NO SIMILAR PRODUCT FROM THE SAME LOT IS AVAILABLE FOR INVESTIGATION. A DOCUMENT BASED INVESTIGATION WAS PERFORMED. A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, DESIGN HISTORY FILES, INSTRUCTIONS FOR USE, AND QUALITY CONTROL DATA WAS CONDUCTED. A REVIEW OF THE DEVICE HISTORY RECORD SHOWS THERE WERE NO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE. A REVIEW OF COMPLAINT HISTORY FOR THE COMPLAINT DEVICE LOT NUMBER 7944524, REVEALED ONE ADDITIONAL COMPLAINT FOR THE SAME ISSUE AND FROM THE SAME CUSTOMER. NO OTHER COMPLAINTS HAVE BEEN RECEIVED ON THIS LOT NUMBER. THE COMPLAINT DEVICE WAS NOT RETURNED. THE EXACT NATURE OF THE COMPLAINT IS NOT CLEAR FROM THE PROVIDED INFORMATION. ADDITIONALLY, A SECOND COMPLAINT WAS REPORTED ON A DEVICE FROM THE SAME LOT BY THE SAME CUSTOMER USING THE SAME EVENT INFORMATION. THE SECOND DEVICE WAS RETURNED AND IT WAS FOUND THE CONDITION OF THE RETURNED DEVICE DID NOT MATCH THE REPORTED INFORMATION. WITHOUT AN ACCURATE DESCRIPTION OF THE EVENT, OR THE DEVICE BEING RETURNED, NO CONCLUSIONS AS TO THE CAUSE OF THE REPORTED ISSUE COULD BE DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. 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

    IT WAS REPORTED THAT THE NCIRCLE TIPLESS STONE EXTRACTOR DISMANTLED DURING A URETEROLITHOTRIPSY. THE HANDLE PIECE DISMANTLED FROM THE EXTRACTOR BODY AND IT WAS RETRIEVED VIA ENDOSCOPY. 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.

    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 TIPLESS STONE EXTRACTOR DISMANTLED DURING A URETEROLITHOTRIPSY. THE HANDLE PIECE DISMANTLED FROM THE EXTRACTOR BODY AND IT WAS RETRIEVED VIA ENDOSCOPY. 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
    425373 NCIRCLE TIPLESS STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC N/A 7944524 00827002187788

    Patients

    Seq Age Sex Outcome Treatment
    1