BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMAGE1 S CONNECT

    MDR report key: 15013353 · Received July 14, 2022

    Report

    Report Number
    15013353
    Event Type
    Malfunction
    Date Received
    July 14, 2022
    Date of Event
    May 6, 2021
    Report Date
    June 30, 2022
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Product Code
    GWG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE KARL STORZ ENDOSCOPY EQUIPMENT TC 201 AND TC 304 MODELS WERE HAVING ISSUES WHERE THE POWER WOULD NOT SHUT OFF AND THE UNITS OCCASIONALLY OVERHEATED. STORZ IDENTIFIED A FIX TO INSULATE THE FRONT COVER OF THE EQUIPMENT, ULTIMATELY REDUCING WATER INTRUSION. IT SEEMED AS THOUGH THE DESIGN OF THE DEVICE WAS NOT MADE TO HANDLE THE CLEANING FLUID, AND WHEN FLUID CAME INTO THE FRONT PANEL, THE POWER BUTTON MALFUNCTIONED. MANUFACTURER RESPONSE FOR ENDOSCOPY CAMERA CONTROL UNIT, IMAGE1 S CONNECT II (PER SITE REPORTER). THE MANUFACTURER DID A FULL EVALUATION, AND FOUND THAT ADDITIONAL INSULATION WAS NECESSARY TO REDUCE WATER INTRUSION ON THE POWER BUTTONS AND ELECTRICAL NETWORKS.

    Description of Event or Problem · 0

    THE KARL STORZ ENDOSCOPY EQUIPMENT TC 201 AND TC 304 MODELS WERE HAVING ISSUES WHERE THE POWER WOULD NOT SHUT OFF AND THE UNITS OCCASIONALLY OVERHEATED. STORZ IDENTIFIED A FIX TO INSULATE THE FRONT COVER OF THE EQUIPMENT, ULTIMATELY REDUCING WATER INTRUSION. IT SEEMED AS THOUGH THE DESIGN OF THE DEVICE WAS NOT MADE TO HANDLE THE CLEANING FLUID, AND WHEN FLUID CAME INTO THE FRONT PANEL, THE POWER BUTTON MALFUNCTIONED. MANUFACTURER RESPONSE FOR ENDOSCOPY CAMERA CONTROL UNIT, IMAGE1 S CONNECT II (PER SITE REPORTER): THE MANUFACTURER DID A FULL EVALUATION, AND FOUND THAT ADDITIONAL INSULATION WAS NECESSARY TO REDUCE WATER INTRUSION ON THE POWER BUTTONS AND ELECTRICAL NETWORKS.

    Description of Event or Problem · 0

    THE KARL STORZ ENDOSCOPY EQUIPMENT TC 201 AND TC 304 MODELS WERE HAVING ISSUES WHERE THE POWER WOULD NOT SHUT OFF AND THE UNITS OCCASIONALLY OVERHEATED. STORZ IDENTIFIED A FIX TO INSULATE THE FRONT COVER OF THE EQUIPMENT, ULTIMATELY REDUCING WATER INTRUSION. IT SEEMED AS THOUGH THE DESIGN OF THE DEVICE WAS NOT MADE TO HANDLE THE CLEANING FLUID, AND WHEN FLUID CAME INTO THE FRONT PANEL, THE POWER BUTTON MALFUNCTIONED. MANUFACTURER RESPONSE FOR ENDOSCOPY CAMERA CONTROL UNIT, IMAGE1 S CONNECT II (PER SITE REPORTER): THE MANUFACTURER DID A FULL EVALUATION, AND FOUND THAT ADDITIONAL INSULATION WAS NECESSARY TO REDUCE WATER INTRUSION ON THE POWER BUTTONS AND ELECTRICAL NETWORKS.

    Description of Event or Problem · 0

    THE KARL STORZ ENDOSCOPY EQUIPMENT TC 201 AND TC 304 MODELS WERE HAVING ISSUES WHERE THE POWER WOULD NOT SHUT OFF AND THE UNITS OCCASIONALLY OVERHEATED. STORZ IDENTIFIED A FIX TO INSULATE THE FRONT COVER OF THE EQUIPMENT, ULTIMATELY REDUCING WATER INTRUSION. IT SEEMED AS THOUGH THE DESIGN OF THE DEVICE WAS NOT MADE TO HANDLE THE CLEANING FLUID, AND WHEN FLUID CAME INTO THE FRONT PANEL, THE POWER BUTTON MALFUNCTIONED. MANUFACTURER RESPONSE FOR ENDOSCOPY CAMERA CONTROL UNIT, IMAGE1 S CONNECT II (PER SITE REPORTER): THE MANUFACTURER DID A FULL EVALUATION, AND FOUND THAT ADDITIONAL INSULATION WAS NECESSARY TO REDUCE WATER INTRUSION ON THE POWER BUTTONS AND ELECTRICAL NETWORKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464060 IMAGE1 S CONNECT ENDOSCOPE, NEUROLOGICAL GWG KARL STORZ ENDOSCOPY-AMERICA, INC. TC201US

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown