BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALM

    MDR report key: 69674 · Received February 12, 1997

    Report

    Report Number
    2027060-1997-09004
    Event Type
    Other
    Date Received
    February 12, 1997
    Date of Event
    January 31, 1997
    Report Date
    February 10, 1997
    Manufacturer
    ALM HOSP EQUIPMENT
    Product Code
    FQP
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, A SMALL PLASTIC COVER (2" DIAMETER) FOR AN ACCESS PORT DROPPED OFF OR WAS KNOCKED OFF OF THE FORK ON A SURGICAL LIGHT AND HIT THE PREPARED STERILE FIELD AND INSTRUMENTS. A HOSP REP REPORTED TO MFR THAT THE INSTRUMENTS HAD TO BE CHANGED OUT. MFR WILL BE REPLACING UNDER WARRANTY, ALL OF THE HOSP'S EXISTING CAPS WITH A RE-DESIGNED RUBBER COVER. THE RE-DESIGNED COVERS ARE MORE RESILIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALM SURGICAL LIGHTING FQP ALM HOSP EQUIPMENT PRC 7501 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other