BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NCIRCLE TIPLESS STONE EXTRACTOR

    MDR report key: 8262134 · Received January 18, 2019

    Report

    Report Number
    1820334-2019-00045
    Event Type
    Injury
    Date Received
    January 18, 2019
    Date of Event
    January 9, 2019
    Report Date
    April 9, 2019
    Manufacturer
    COOK INC
    Product Code
    FFL
    UDI-DI
    00827002187788
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. 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, MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL DATA. ONE STONE EXTRACTOR WAS RETURNED FOR INVESTIGATION. RETURNED PACKAGING CONFIRMS LOT NUMBER 9251812. THE DEVICE WAS RETURNED WITH THE HANDLE IN THE CLOSED POSITION. THE MALE LUER LOCK ADAPTER (MLLA) IS LOOSE. THE COLLET KNOB IS TIGHT AND SECURE. THE POLYETHYLENE TEREPHTHALATE TUBING (PETT) MEASURES 2.5 CM IN LENGTH. FUNCTIONAL TESTING DETERMINED THE HANDLE DOES NOT ACTUATE. VISUAL EXAMINATION NOTED TWO KINKS IN THE BASKET SHEATH, ONE LOCATED 77 CM FROM DISTAL TIP OF THE BASKET SHEATH, AND ONE LOCATED 85.8 CM FROM THE DISTAL TIP OF BASKET SHEATH THE COIL ASSEMBLY CAN BE MANUALLY ACTUATED. WHEN THE COIL ASSEMBLY WAS REMOVED FROM THE BASKET SHEATH, THE BASKET FORMATION AND DISTAL CANNULA WERE FOUND TO BE MISSING. THE COIL ASSEMBLY MEASURES 112.1 CM IN LENGTH. THE CANNULATED HANDLE MEASURES 15.1 CM IN LENGTH. THE BASKET SHEATH AND SUPPORT SHEATH ARE STILL ADHERED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NON-CONFORMANCES THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED FAILURE MODE. A REVIEW OF COMPLAINT HISTORY RECORDS REVEALED THERE HAVE BEEN NO OTHER COMPLAINTS ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER 9251812. THE INSTRUCTIONS FOR USE (IFU) CONTAINS THE FOLLOWING PRECAUTIONS: 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. THE RETURNED DEVICE WAS FOUND TO BE MISSING THE BASKET. THE BASKET CANNULA AND BASKET WIRES HAD SEPARATED AT THE DISTAL END OF THE COIL. TWO OF THE BASKET WIRES RUN THE LENGTH OF THE DEVICE AND ARE ATTACHED TO HANDLE. BOTH OF THESE WIRES BROKE, AND THE BASKET CANNULA THAT IS GLUED TO THE DISTAL END OF THE COIL HAD PULLED OFF. ALL DEVICES UNDERGO A TENSILE TEST TO ENSURE THE INTEGRITY OF THE DEVICE. THE HANDLE IS HELD AND THE BASKET IS PULLED WITH A FORCE OF 5N. THE COMPLAINT DEVICE PASSED THE TENSILE TEST. A POSSIBLE CAUSE FOR THE SEPARATION OF THE BASKET ASSEMBLY IS THAT AN ABNORMAL TENSILE FORCE WAS APPLIED TO THE DEVICE DURING USE, BREAKING THE TWO BASKET WIRES AND PULLING THE BASKET CANNULA OFF OF THE COIL. THE IFU CONTAINS A PRECAUTION THAT EXCESSIVE FORCE MAY DAMAGE THE DEVICE. THERE IS NO INFORMATION INDICATING THAT AN ABNORMAL AMOUNT OF FORCE WAS APPLIED TO THE DEVICE DURING USE. A DEFINITIVE CAUSE FOR THE BREAKAGE COULD NOT BE ESTABLISHED. 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 · 0

    INVESTIGATION ¿ EVALUATION THE BASKET FORMATION PORTION OF THE DEVICE WAS RETURNED FOR INVESTIGATION. THE BASKET WAS FOUND TO BE HEAVILY ENCRUSTED FROM THE TIME IN THE PATIENT. ONE OF THE BASKET WIRES WAS FOUND TO BE BROKEN. THE END OF THE BROKEN WIRE WAS TINTED AND SLIGHTLY MELTED IN APPEARANCE, INDICATING THE WIRE BROKE DUE TO EXPOSURE TO A LASER. THE WIRES AT THE PROXIMAL END OF THE BASKET WERE BROKEN PROXIMAL OF THE BASKET CANNULA. THE ADDITIONAL INFORMATION RECEIVED DID NOT CHANGE THE ORIGINAL CONCLUSION CODE OF CAUSE NOT ESTABLISHED. PER THE QUALITY ENGINEERING RISK ASSESSMENT 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.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED 11MAR2019: IT WAS REPORTED THAT A PORTION OF THE DEVICE HAD REMAINED IN THE PATIENT. AN ADDITIONAL PROCEDURE WAS REQUIRED TO REMOVE A PORTION OF THE BROKEN DEVICE. TO DATE THERE HAVE BEEN NO OTHER KNOWN PATIENT ADVERSE EFFECTS REPORTED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: OLYMPUS CYSTOSCOPE, OLYMPUS URETEROSCOPE, HLF-S273-HSMA, MHW-035150. NON-HEALTHCARE PROFESSIONAL- MATERIALS MANAGEMENT. PMA/510K # : EXEMPT .(B)(4). 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 DURING A CYSTOSCOPY, URETEROSCOPY, AND STONE EXTRACTION FROM THE KIDNEY AND URETER USING A NCIRCLE TIPLESS STONE EXTRACTOR, THE BASKET BROKE AWAY FROM THE TIP OF THE WIRE MECHANISM. PIECES OF THE NITINOL BASKET REMAINED IN THE URETER. THE PHYSICIAN USED A SECOND BASKET TO REMOVE THE DEBRIS. IT IS UNCERTAIN IF ALL OF THE PIECES OF THE BASKET WERE RETRIEVED. THE PHYSICIAN IS UNCERTAIN IF THE PATIENT WILL REQUIRE AN ADDITIONAL PROCEDURE IN THE FUTURE DUE TO THIS ISSUE. NO ADVERSE OUTCOMES HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION AT THIS TIME. 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
    55364 NCIRCLE TIPLESS STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC G18778 9251812 00827002187788

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention