BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUP BIOPSY FORCEPS

    MDR report key: 8112898 · Received November 28, 2018

    Report

    Report Number
    1820334-2018-03569
    Event Type
    Malfunction
    Date Received
    November 28, 2018
    Date of Event
    February 25, 2016
    Report Date
    November 28, 2018
    Manufacturer
    COOK INC
    Product Code
    OCZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD FOR SECTION COULD NOT BE POPULATED DUE TO A TECHNICAL LIMITATION. SECTION COMMON NAME: ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED SECTION PRODUCT CODE: OCZ. 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 IN FLEXIBLE URETEROSCOPY PROCEDURE, THE SHEATH (OUTER LAYER) OF THE FORCEPS SEPARATED COMPLETELY FROM THE METALLIC PART (COIL) OF THE SHEATH. THIS OCCURRED INSIDE THE SCOPE AND OUTSIDE OF THE PATIENT. IT WAS FURTHER NOTED THAT THE SMALL SCOPE HAD SCRAPED THE SHEATH OFF THE COIL ASSEMBLY. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT REPORTED DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    949211 CUP BIOPSY FORCEPS OCZ COOK INC NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1