BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WITTICH NITINOL STONE BASKET

    MDR report key: 8354629 · Received February 20, 2019

    Report

    Report Number
    1820334-2019-00456
    Event Type
    Malfunction
    Date Received
    February 20, 2019
    Date of Event
    November 20, 2018
    Report Date
    August 27, 2020
    Manufacturer
    COOK INC
    Product Code
    LQR
    UDI-DI
    00827002058774
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: UPON FURTHER REVIEW, IT WAS DETERMINED THAT THIS EVENT IS NOT REPORTABLE PER 21CFR PART 803.50 AS IT DOES NOT MEET THE CRITERIA FOR A DEATH, SERIOUS INJURY OR REPORTABLE PRODUCT MALFUNCTION. A REVIEW OF REPORTING SOFTWARE REVEALED THERE ARE NO PREVIOUS INCIDENTS OF HUB SEPARATION OF THE RSSW SHEATH THAT LEAD TO A DEATH OR SERIOUS INJURY. ADDITIONALLY, REVIEW OF RISK DOCUMENTATION INDICATED THAT THIS MALFUNCTION IS NOT LIKELY TO CAUSE SERIOUS INJURY IF IT WERE TO REOCCUR. 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    COMMON NAME: DISLODGER, STONE, BILIARY. PRO CODE: LQR. PMA/510K #: K902944. INVESTIGATION ¿ EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, SPECIFICATIONS, AND A VISUAL INSPECTION OF THE RETURNED DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THAT THE PROXIMAL HUB (CAP AND ADAPTOR) SEPARATED FROM THE SHEATH MATERIAL. A CREASE WITHIN THE FLARE WAS NOTED, INDICATING THE SHEATH MATERIAL WAS CAUGHT BETWEEN THE CAP AND ADAPTOR. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THE LOT WAS RELEASED MEETING ALL FINISHED GOODS RELEASE CRITERIA. IT SHOULD BE NOTED THERE WAS ONE OTHER REPORTED COMPLAINT FOR THIS LOT NUMBER. BASED ON THE INFORMATION PROVIDED, THE EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED THAT THE DEVICE VALVE SEPARATED FROM THE CATHETER WHEN THE OPERATOR TRIED TO PULL THE BILIARY STONE OUT. NO PATIENT ADVERSE EVENTS RESULTED FROM THE MALFUNCTIONING OF THE DEVICE, AND THE COMPLAINT DEVICE WAS EXCHANGED FOR A NEW DEVICE WITH NO CONSEQUENCES FOR THE PATIENT. IT WAS LATER DISCOVERED DURING THE INVESTIGATION OF THE RETURNED DEVICE THAT IT WAS THE HUB OF THE DEVICE WHICH SEPARATED FROM THE SHEATH MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149433 WITTICH NITINOL STONE BASKET LQR COOK INC G05877 8366076 00827002058774

    Patients

    Seq Age Sex Outcome Treatment
    1