BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERC NCIRCLE NITINOL TIPLESS STONE EXTRACTOR

    MDR report key: 8261719 · Received January 18, 2019

    Report

    Report Number
    1820334-2019-00128
    Event Type
    Malfunction
    Date Received
    January 18, 2019
    Date of Event
    January 16, 2019
    Report Date
    February 8, 2019
    Manufacturer
    COOK INC
    Product Code
    FFL
    UDI-DI
    00827002328624
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION. A VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE RETURNED DEVICE WAS CONDUCTED. A DOCUMENT BASED INVESTIGATION WAS ALSO PERFORMED INCLUDING A REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORD, THE INSTRUCTIONS FOR USE, AND QUALITY CONTROL DATA. TWO DEVICES WERE RETURNED FOR INVESTIGATION. RETURNED PACKAGING CONFIRMS LOT NUMBER 9022506. DEVICE A VISUAL EXAMINATION NOTES THE CANNULA IS BENT 2 CM FROM PROXIMAL END. FUNCTIONAL TESTING DETERMINED THE HANDLE ACTUATES TO THE BEND IN THE CANNULA, THEN DRAGS, WITH FORCE, THE HANDLE RETRACTS THE BASKET FORMATION. DEVICE B VISUAL EXAMINATION NOTES THE CANNULA IS BROKEN AT THE PROXIMAL END, NEAR THE SOLDER. A REVIEW OF THE DEVICE HISTORY RECORD FOUND THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH LOT 9022506. A REVIEW OF COMPLAINT HISTORY RECORDS SHOWS THERE ARE NO OTHER COMPLAINTS ASSOCIATED WITH THE COMPLAINT DEVICE LOT 9022506. THE INSTRUCTIONS FOR USE (IFU) PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: CAUTION: THIS DEVICE IS CONDUCTIVE. AVOID CONTACT WITH ANY ELECTRIFIED INSTRUMENT. CAUTION: STERILE IF THE PACKAGE IS UNOPENED OR UNDAMAGED. DO NOT USE IF PACKAGE IS BROKEN. IMPORTANT: ENCLOSE DEVICE IN SHEATH BEFORE REMOVING FROM TRAY/HOLDER. IMPORTANT: EXCESSIVE FORCE COULD DAMAGE DEVICE. 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. ALL DEVICES ARE INSPECTED FOR FUNCTIONALITY AND DAMAGE PRIOR TO PACKAGING AND ARE PACKAGED WITH THE BASKET OPEN. BOTH DEVICES WERE FOUND TO BE NONFUNCTIONAL DUE TO DAMAGE TO THE HANDLE CANNULA. THE CANNULA FOR ONE DEVICE WAS BENT, AND THE OTHER WAS SEPARATED. BOTH THE OF THESE DEVICES, AND A THIRD DEVICE FROM A DIFFERENT LOT WERE ALL USED IN THE SAME PROCEDURE. ALL 3 DEVICES WERE FOUND TO HAVE FUNCTIONAL ISSUES DUE TO DAMAGE TO THE HANDLE CANNULA. HAVING THREE DEVICES FROM TWO DIFFERENT LOTS DAMAGED IN A ROW INDICATES A POTENTIAL ISSUE RELATED TO THE PROCEDURE, POSSIBLY THE SCOPE OR THE TECHNIQUE. IT IS ALSO POSSIBLE THESE DEVICES WERE DAMAGED DURING SHIPPING/HANDLING. A DEFINITIVE CAUSE FOR THE OBSERVED DAMAGE TO THE DEVICES 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.

    Description of Event or Problem · 0

    THERE HAS BEEN NO NEW INFORMATION RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.

    Additional Manufacturer Narrative · 1

    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 DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE, THE INNER CANNULA OF THE PERC NCIRCLE NITINOL TIPLESS STONE EXTRACTOR BASKET WAS EITHER BENT OR BROKEN. THE INNER CANNULA WAS NOT CONNECTING TO THE RED HANDLE. THIS OCCURRED WITH THREE DEVICES IN THE SAME PROCEDURE, TWO (2) FROM LOT 9022506 AND 1 EACH FROM LOT 9016107. THEY DID NOT TRY TO RETRIEVE THE STONE WITH THESE DEVICES. THE SEPARATED PART (METAL CANNULA THAT ATTACHED TO THE HANDLE) WAS OUTSIDE OF THE PATIENT¿S BODY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A FOURTH DEVICE. NO ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THESE OCCURRENCES AND THERE WERE NO ADVERSE EFFECTS ON THE PATIENT. THE TWO PERC NCIRCLE NITINOL TIPLESS STONE EXTRACTORS FROM LOT # 9022506 HAVE BEEN ADDRESSED IN THIS REPORT (MFR REPORT # 1820334-2019-00128). THE SINGLE PERC NCIRCLE NITINOL TIPLESS STONE EXTRACTOR FROM LOT # 9016107 IS ADDRESSED IN THE RELATED MFR REPORT # 1820334-2019-00129.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54385 PERC NCIRCLE NITINOL TIPLESS STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC 9022506 00827002328624

    Patients

    Seq Age Sex Outcome Treatment
    1