BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER INSTRUMENTS

    MDR report key: 8268911 · Received January 22, 2019

    Report

    Report Number
    1047429-2019-00001
    Event Type
    Malfunction
    Date Received
    January 22, 2019
    Date of Event
    August 1, 2018
    Report Date
    January 22, 2019
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AVID MEDICAL IS THE MANUFACTURER OF CUSTOM PROCEDURE TRAY, CINC106-08 CUSTOM EYE PACK (LOT: 1321385), THAT INCLUDES THE COMPLAINT COMPONENT, SM-8416-7B GAUZE SPONGE 8X4 10S XR BARCODED 16 PLY SURGICOUNT (VENDOR LOT: 108097) MANUFACTURED BY STRYKER INSTRUMENTS. AVID MEDICAL RECEIVED COMPLAINT ON 12/26/18 ORIGINATED BY (B)(6), MEDICAL PROFESSIONAL AT (B)(6) MEDICAL CENTER - (B)(6). END-USER REPORTS THAT THE GAUZE THAT WAS IN THE PACK HAD LOOSE LINT DEBRIS AND WAS TOO COARSE AND ABRASIVE FOR USE AROUND PATIENT'S EYES. THE SPONGES LEAVE DEBRIS RESIDUE WHICH HAS GOTTEN ON THE INSTRUMENTS AND THE STERILE RINSE WATER. ON POST-OP EXAMINATION, SMALL DEBRIS FLECKS WERE NOTED IN THE EYES OF PATIENT. AVID MEDICAL ISSUED FORMAL COMPLAINT # (B)(4) TO THE MANUFACTURER STRYKER INSTRUMENTS CONCERNING THE GAUZE COMPLAINT FOR ITEM NO. SM-8416-7B, MANUFACTURER LOT# 108097. NO PATIENT INJURY OR ADDITIONAL MEDICAL INTERVENTION WAS REPORTED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62210 STRYKER INSTRUMENTS GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE GDY STRYKER INSTRUMENTS SM-8416-7B 108097

    Patients

    Seq Age Sex Outcome Treatment
    1