BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK FLEXIBLE MYOCARDIAL BIOPSY FORCEPS

    MDR report key: 8173808 · Received December 18, 2018

    Report

    Report Number
    1820334-2018-03842
    Event Type
    Malfunction
    Date Received
    December 18, 2018
    Date of Event
    January 12, 2017
    Report Date
    December 18, 2018
    Manufacturer
    COOK INC
    Product Code
    DWZ
    UDI-DI
    00827002053892
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMMON NAME: DEVICE, BIOPSY, ENDOMYOCARDIAL. PRODUCT CODE: DWZ. THIS MDR IS BEING FILED AFTER THE ASSOCIATED COMPLAINT WAS REVIEWED UNDER REMEDIATION PROTOCOL (B)(4), COMPLAINT/MDR RETROSPECTIVE REVIEW AND REMEDIATION AND REASSESSED AS REPORTABLE. ADDITIONAL COMPLAINT INVESTIGATION AND RECORD REMEDIATION WAS NOT PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE BIOPSY OF LEFT VENTRICLE, THE FLEXIBLE MYOCARDIAL BIOPSY FORCEPS WOULD NOT OPEN INSIDE THE PATIENT WHEN ADVANCED THROUGH THE GUIDING CATHETER. AFTER THE PROCEDURE, THE USER CHECKED IF THE DEVICE SHAFT OF THE DEVICE WAS BENT. IT WAS FURTHER NOTED THAT THE HANDLE WOULD NOT ACTUATE THE FORCEPS DUE TO A MISSING RIVET AND INTERNAL CORROSION. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1014694 COOK FLEXIBLE MYOCARDIAL BIOPSY FORCEPS DWZ COOK INC NA 6515681 00827002053892

    Patients

    Seq Age Sex Outcome Treatment
    1