BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N-COMPASS NITINOL STONE EXTRACTOR

    MDR report key: 11273043 · Received February 3, 2021

    Report

    Report Number
    1820334-2021-00242
    Event Type
    Malfunction
    Date Received
    February 3, 2021
    Date of Event
    December 23, 2020
    Report Date
    April 1, 2021
    Manufacturer
    COOK INC
    Product Code
    LQR
    UDI-DI
    10827002362519
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. 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

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. CORRECTION: D - PRODUCT IDENTIFIER, D4 - RPN. INVESTIGATION - EVALUATION. BEIJING PRIME MEDICAL EQUIPMENT CO., LTD INFORMED COOK ON (B)(6) 2021 OF AN INCIDENT INVOLVING A N-COMPASS NITINOL STONE EXTRACTOR C-C-NTSE-2.4-115-NCT4 FROM LOT # 10054185. THE TIP OF THE BASKET OF REPORTEDLY COULD NOT BE ADVANCED BEFORE USE ON (B)(6) 2020. A REVIEW OF DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS AND QUALITY CONTROL, AS WELL AS A VISUAL INSPECTION AND FUNCTIONAL TEST OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. ONE N-COMPASS NITINOL STONE EXTRACTOR WAS RETURNED FOR EVALUATION. THE DEVICE WAS FOUND TO HAVE A BASKET THAT WAS CLOSED AND COULD NOT BE OPENED DUE TO EXTENSIVE DAMAGE TO THE DEVICE. THE MALE LUER LOCK ADAPTER THAT SECURED THE BASKET SHEATH TO THE HANDLE WAS MISSING AND THE CANNULATED HANDLE WAS FOUND TO BE SEVERELY BENT. THE SUPPORT SHEATH AND BASKET SHEATH WERE STILL ADHERED. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) FOUND THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE PRODUCT SPECIFICATION FOR THE N-COMPASS NITINOL STONE EXTRACTOR C-C-NTSE-2.4-115-NCT4 WAS REVIEWED AND ALL EXTRACTORS ARE 100% VERIFIED TO ASSURE THE BASKET OPENS AND CLOSES PROPERLY. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR LOT 10054185 FOUND NO RELEVANT NONCONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. IT SHOULD BE NOTED THAT THERE WERE NO OTHER COMPLAINTS ASSOCIATED WITH THIS LOT NUMBER. BECAUSE THERE WERE NO RELATED NON-CONFORMANCES, ADEQUATE INSPECTION ACTIVITIES HAVE BEEN ESTABLISHED, THERE IS OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, AND NO OTHER LOT RELATED COMPLAINTS HAVE BEEN RECEIVED FROM THE FIELD, 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 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. BASED ON THE INFORMATION PROVIDED, EXAMINATION OF THE RETURNED PRODUCT AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE FOR THE FAILURE COULD NOT BE DETERMINED. THE PROVIDED INFORMATION STATED THE ISSUE OCCURRED BEFORE PATIENT CONTACT. IT IS POSSIBLE THE DEVICE WAS DAMAGED DURING UNPACKING AND/OR SUBSEQUENT HANDLING. IT IS ALSO POSSIBLE THAT THE DEVICE WAS DAMAGED DURING SHIPPING, OR WHEN LOADING THE DEVICE INTO THE DEVICE TRAY. THERE IS NOT ENOUGH EVIDENCE TO MAKE A CONCLUSION AS TO THE CAUSE OF THE DAMAGE. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. WE WILL CONTINUE TO MONITOR 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

    IN ADDITIONAL INFORMATION RECEIVED ON 08MAR2021, IT WAS REPORTED THAT ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE INTENDED PROCEDURE WITHOUT ANY ADVERSE EFFECTS TO THE PATIENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: K173009. 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 PRIOR TO USE, THE TIP OF THE BASKET OF A N-COMPASS NITINOL STONE EXTRACTOR WAS UNABLE TO BE ADVANCED. THE DEVICE DID NOT MAKE PATIENT CONTACT. ADDITIONAL INFORMATION REGARDING THE PATIENT AND EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171124 N-COMPASS NITINOL STONE EXTRACTOR LQR DISLODGER, STONE BILIARY LQR COOK INC 10054185 10827002362519

    Patients

    Seq Age Sex Outcome Treatment
    1