BEUDAMED
    FDA Adverse Event Death Summary report: N

    PKG, CONNECTED OR HUB BASE SYSTEM

    MDR report key: 12712067 · Received October 28, 2021

    Report

    Report Number
    0002936485-2021-00581
    Event Type
    Death
    Date Received
    October 28, 2021
    Date of Event
    September 30, 2021
    Report Date
    May 2, 2024
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    OUG
    UDI-DI
    07613327413281
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. ALLEGED FAILURE: 2 PLASTIC FEET CAME OFF THE UNIT. THE OTHER 2 FEET WERE REMOVED AND CAUSED THE UNIT TO OVERHEAT. WHEN THE UNIT OVERHEATED THERE WAS STILL SOME FUNCTIONALITY BUT NOT 100%. THE PROBABLE ROOT CAUSES COULD BE DUE TO FOUR MISSING PLASTIC LOCK-IN FEET; POSSIBLY REMOVED PRIOR TO USE. WHILE STACKED ABOVE ANOTHER CONSOLE, THE VENTILATION ON THE OR HUB UNDERSIDE WAS BLOCKED; CAUSING THE CAPTURE CARD TO OVERHEAT. THE DEVICE MANUFACTURE DATE IS NOT KNOWN.

    Additional Manufacturer Narrative · 0

    UPDATING TO NO LONGER REPORTABLE BASED ON MEDICAL OPINION WHICH DETERMINED THE REPORTED FAILURE MODE WITH THE CONNECTED OR HUB HAD NO IMPACT ON THE SURGEON OR PROCEDURE OTHER THAN THE LOSS OF THE ABILITY TO TRANSFER AND STORE DATA, IMAGES, AND VIDEO. THE MAIN SOURCE OF THE VIDEO WAS UNAFFECTED AND THAT THE REPORTED FAILURE MODE DID NOT CONTRIBUTE TO THE REPORTED EVENT. ADDITIONALLY, THE MEDICAL OPINION POSITS THAT THE COMPLAINT DEVICE IS NOT INTENDED FOR USE FOR ACTIVE PATIENT MONITORING. RATHER, THE PURPOSE OF CAPTURING DATA, IMAGES OR VIDEO DURING ENDOSCOPY IS TO AID IN A POST-EXAMINATION REVIEW OF FINDINGS, SHARE INFORMATION AND TO ALLOW COMPARISON WITH PREVIOUS FINDINGS IF ANY LESIONS ARE DETECTED BY ENDOSCOPY AT A LATER DATE. AS SUCH, THIS REPORTED EVENT IS NO LONGER CONSIDERED REPORTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS LOST DURING PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS LOST DURING PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS LOST DURING PROCEDURE. THIS INITIAL REPORT WAS PREVIOUSLY DETERMINED TO BE A SERIOUS INJURY. BASED ON MEDICAL OPINION WHICH DETERMINED THE REPORTED FAILURE MODE WITH THE CONNECTED OR HUB HAD NO IMPACT ON THE SURGEON OR PROCEDURE OTHER THAN THE LOSS OF THE ABILITY TO TRANSFER AND STORE DATA, IMAGES, AND VIDEO. THE MAIN SOURCE OF THE VIDEO WAS UNAFFECTED AND THAT THE REPORTED FAILURE MODE DID NOT CONTRIBUTE TO THE REPORTED EVENT. ADDITIONALLY, THE MEDICAL OPINION POSITS THAT THE COMPLAINT DEVICE IS NOT INTENDED FOR USE FOR ACTIVE PATIENT MONITORING. RATHER, THE PURPOSE OF CAPTURING DATA, IMAGES OR VIDEO DURING ENDOSCOPY IS TO AID IN A POST-EXAMINATION REVIEW OF FINDINGS, SHARE INFORMATION AND TO ALLOW COMPARISON WITH PREVIOUS FINDINGS IF ANY LESIONS ARE DETECTED BY ENDOSCOPY AT A LATER DATE. AS SUCH, THIS REPORTED EVENT IS NO LONGER CONSIDERED REPORTABLE.

    Additional Manufacturer Narrative · 1

    THE DEVICE MANUFACTURE DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS. ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS LOST DURING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1609398 PKG, CONNECTED OR HUB BASE SYSTEM MEDICAL DEVICE DATA SYSTEM OUG STRYKER ENDOSCOPY-SAN JOSE 07613327413281

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death