BEUDAMED
    FDA Adverse Event Other Summary report: N

    STRYKER ENDOSCOPY

    MDR report key: 152850 · Received January 30, 1998

    Report

    Report Number
    152850
    Event Type
    Other
    Date Received
    January 30, 1998
    Date of Event
    August 26, 1997
    Report Date
    September 18, 1997
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    KNS
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT IS 57 YR FEMALE WHO UNDERWENT A LAPAROSCOPIC CHOLECYSTECTOMY ON 8/26/97. AT THE END OF THE SURGICAL PROCEDURE, THE STERILE DRAPES WERE REMOVED. AN AREA OF RAISED, REDDENED TISSUE WAS NOTED ON PT'S ABDOMEN, CENTERED AMONG THE THREE INCISION SITES. IN THE CENTER OF THE REDDENED AREA (ABOUT 3" DIAMETER) WAS A DIME-SIZED, FLUID FILLED AREA. AREA TREATED, DRESSED AND BANDAGED PRIOR TO PT'S DISCHARGE (LATER ON 8/26/97).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER ENDOSCOPY SPATULA (1) CAUTERY (2) RIGHT ANGLE CAUTERY KNS STRYKER ENDOSCOPY (1) 250-040-101 *

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other GRASPING FORCEPS, SCISSORS, CAUTERY UNIT.