BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NFORCE NITINOL HELICAL STONE EXTRACTOR

    MDR report key: 9612434 · Received January 21, 2020

    Report

    Report Number
    1820334-2020-00179
    Event Type
    Malfunction
    Date Received
    January 21, 2020
    Date of Event
    January 8, 2020
    Report Date
    March 5, 2020
    Manufacturer
    COOK INC
    Product Code
    FFL
    UDI-DI
    10827002179407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION/EVALUATION: A USER FACILITY INFORMED COOK ON 01/14/2020 OF AN INCIDENT INVOLVING A NFORCE NITINOL HELICAL STONE EXTRACTOR NFHSES-032115-3W-UDH FROM LOT#: 9962303. THE BASKET OF THE DEVICE REPORTEDLY WOULD NOT CLOSE BEFORE USE DURING A RIGID URETEROSCOPY STONE EXTRACTION PROCEDURE ON (B)(6) 2020. THE PATIENT REPORTEDLY EXPERIENCED NO ADDITIONAL HARM AS A RESULT OF THE ISSUE. 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, DRAWINGS, THE INSTRUCTIONS FOR USE, AND QUALITY CONTROL DATA. ONE N-FORCE NITINOL HELICAL STONE EXTRACTOR WAS RETURNED FOR INVESTIGATION. INSPECTION OF THE RETURNED DEVICE NOTED THAT THE DEVICE WAS RETURNED WITH THE HANDLE AND BASKET FORMATION IN THE OPEN POSITION. THE MLLA (MALE LUER LOCK ADAPTER) WAS LOOSE, WHILE THE COLLET KNOB WAS TIGHT AND SECURE. THE POLYTHYLENE TEREPHTHALATE TUBING (PETT) WAS NOT RETURNED. IT WAS NOTED THAT 2.2 CM OF THE COIL ASSEMBLY PROTRUDED FROM THE DISTAL END OF THE BASKET SHEATH. THE BASKET SHEATH WAS ACCORDIONED 2 MM FROM THE DISTAL END OF THE SUPPORT SHEATH. FUNCTIONAL TESTING OF THE DEVICE DETERMINED THAT THE HANDLE WAS ABLE TO MOVE THE BASKET FORMATION. THE BASKET FORMATION DID NOT RETRACT INTO THE BASKET SHEATH WHEN THE HANDLE WAS ACTUATED. THE HANDLE WAS DISASSEMBLED. THE BASKET HEATH AND SUPPORT SHEATH WERE STILL ADHERED. THE BASKET FORMATION COULD NOT BE MANUALLY ACTUATED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE MODE. A REVIEW OF THE COMPLAINT HISTORY RECORDS FOUND THAT THERE WERE ONE OTHER COMPLAINT ASSOCIATED WITH THE COMPLAINT DEVICE LOT. THE OTHER COMPLAINT WAS REPORTED BY A DIFFERENT CUSTOMER AND THE DEVICE(S) WAS NOT RETURNED, BUT IT WAS NOTED THAT THEY WERE REPORTED TO HAVE BEEN USED OFF-LABEL. BECAUSE THERE ARE NO NON-CONFORMANCES, ADEQUATE INSPECTION ACTIVITIES HAVE BEEN ESTABLISHED, THERE IS OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, AND NO OTHER COMPLAINTS RECEIVED FROM THE FIELD WERE DETERMINED TO HAVE A RELATED FAILURE, 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. A (RIC) REQUEST TO INITIATE A CAPA (CORRECTIVE AND PREVENTIVE ACTION) WAS SUBMITTED, BUT IT WAS DETERMINED THAT ESCALATION WAS NOT REQUIRED. THE COMPLAINT DEVICE WAS FOUND TO HAVE A BASKET THAT WAS OPEN AND COULD NOT BE CLOSED. THE SHEATH WAS FOUND TO BE DAMAGED. THE SHEATH WAS BUCKLED NEAR THE BLUE STRAIN RELIEF AT THE HANDLE. THE SHEATH DAMAGE WAS PREVENTING THE BASKET FROM CLOSING. THE ISSUE OCCURRED BEFORE DEVICE USE, THEREFORE THE DEVICE MAY HAVE BEEN DAMAGED FROM HANDLING EITHER DURING PACKAGING OR DURING REMOVAL OF THE DEVICE FROM THE PACKAGING. THERE IS NOT ENOUGH EVIDENCE TO MAKE A CONCLUSIVE DETERMINATION OF THE CAUSE OF THE SHEATH DAMAGE. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. COOK MEDICAL 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

    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, PRIOR TO A RIGID URETEROSCOPY/STONE EXTRACTION PROCEDURE USING A NFORCE NITINOL HELICAL STONE EXTRACTOR, IT WAS IMPOSSIBLE TO CLOSE THE DEVICE. THE DIFFICULTY OCCURRED TESTING OF THE DEVICE AND PRIOR TO USE ON THE PATIENT. THE SURGEON USED ANOTHER SAME TYPE DEVICE TO COMPLETE THE PROCEDURE. NO ADVERSE EFFECTS HAVE BEEN REPORTED DUE TO THE ALLEGED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76170 NFORCE NITINOL HELICAL STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC 9962303 10827002179407

    Patients

    Seq Age Sex Outcome Treatment
    1 CYSTOSCOPE, WIRE, RIGID URETEROSCOPE