BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 2123031 · Received June 11, 2011

    Report

    Report Number
    9610617-2011-00023
    Event Type
    Other
    Date Received
    June 11, 2011
    Date of Event
    May 8, 2011
    Report Date
    June 9, 2011
    Manufacturer
    KARL STORZ GMBH & CO. KG
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) I SUBMITTED NOTED THAT THE SIZE OF THE BROKEN PIECE WAS .5MM X 5MM; IT SHOULD HAVE BEEN NOTED AS 5MM X 5MM. I HAVE UPDATED TEXT IN DESCRIPTION AND RESENT THIS MDR TO APPROPRIATE FDA ADDRESS.

    Description of Event or Problem · 1

    ALLEGEDLY, AT THE CONCLUSION OF AN ENDOCHOLECYSTECTOMY, DOCTOR NOTICED THAT A SMALL PIECE (5MM X 5MM) OF SLIDING CONE HAD BROKEN OFF. OPERATING ROOM PERSONNEL COULD NOT LOCATE BROKEN PIECE SO DOCTOR USED CAMERA TO VIEW ABDOMEN BUT THE PIECE WAS NOT FOUND. THEY SUSPECT IT MAY REMAIN IN PATIENT. PROCEDURE WAS COMPLETED AND PATIENT CONDITION POST-OP WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ SLIDING CONE WITH ANCHORS KNS KARL STORZ GMBH & CO. KG 30103C1 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other