BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANN H.F. DGNST 6MM RTBL DBL VLV

    MDR report key: 10737739 · Received October 26, 2020

    Report

    Report Number
    1219602-2020-01660
    Event Type
    Injury
    Date Received
    October 26, 2020
    Date of Event
    October 6, 2020
    Report Date
    April 6, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    NBH
    UDI-DI
    03596010573520
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE, USED IN TREATMENT, WAS NOT RETURNED TO THE DESIGNATED COMPLAINT FACILITY FOR INDEPENDENT EVALUATION, THUS VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. A RELATIONSHIP, IF ANY, BETWEEN THE SUBJECT DEVICE AND THE REPORTED EVENT COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION OR WOULD NOT BE ABLE TO PERFORM AS INTENDED. A COMPLAINT HISTORY REVIEW CONCLUDED THIS WAS A REPEAT ISSUE. PLEASE REFER TO THE INSTRUCTIONS FOR USE FOR RECOMMENDATIONS ON PROPER USE OF THE DEVICE AND POTENTIAL TROUBLESHOOTING METHODS TO PREVENT FUTURE REOCCURRENCE OF THE REPORTED EVENT. THE CANN H.F. DGNST 6MM RTBL DBL VLV INSTRUCTIONS FOR USE WARNS, ¿PRIOR TO USE, INSPECT THE DEVICE TO ENSURE IT IS NOT DAMAGED. DO NOT USE A DAMAGED DEVICE.¿ A REVIEW OF THE CANN H.F. DGNST 6MM RTBL DBL VLV RISK MANAGEMENT FILES WAS PERFORMED AND FOUND MULTIPLE LINE ITEMS ADDRESSING THIS FAILURE MODE. IF THE PRODUCT ASSOCIATED WITH THIS EVENT IS RETURNED AT A FUTURE DATE, THIS INVESTIGATION WILL BE REOPENED FOR EVALUATION. INTERNAL COMPLAINT REFERENCE: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING SURGERY, AT THE MOMENT THE "6MM HIGH FLOW CANNULA" WAS INSERTED IN THE POINT, THE SURGICAL STAFF REALIZED THAT THE METAL PART IN THE CANNULA WAS THROUGH THE COAGULATION. THEY IDENTIFIED THAT WAS LOOSE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO ADDITIONAL COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1202477 CANN H.F. DGNST 6MM RTBL DBL VLV ACCESSORIES,ARTHROSCOPIC NBH SMITH & NEPHEW, INC. 72200829 50557876 03596010573520

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention