BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FG SAFELIGHT FIBER OPTIC CABLE WITH ADVANCED IMAGING MODALITY 5 MM

    MDR report key: 19383135 · Received May 23, 2024

    Report

    Report Number
    0002936485-2024-00414
    Event Type
    Malfunction
    Date Received
    May 23, 2024
    Date of Event
    April 30, 2024
    Report Date
    July 31, 2024
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    OWN
    PMA / PMN Number
    K192292
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    ALLEGED FAILURE: CAN YOU PLEASE PROCESS THE FOLLOWING COMPLAINT/CREDIT RETURN AND REPLACEMENT. EVENT DATE 4/29/2024 EVENT ¿ SAFELIGHT CABLE DOES NOT TURN OFF WHEN DISCONNECTED FROM THE SAFELIGHT ADAPTER AFFECTED ITEMS: PN SN, 220-240-300 23I554424, 233-050-087 23J5642, 233-050-400 (B)(6). PATIENT INVOLVEMENT ¿ YES, NO IMPACT. NO SURGICAL DELAY. CASE COMPLETED SUCCESSFULLY. NO MEDICAL INTERVENTION. THE FAILURE(S) IDENTIFIED IN THE INVESTIGATION IS CONSISTENT WITH THE COMPLAINT RECORD. THE PROBABLE ROOT CAUSE/S COULD BE A REED SWITCH. OTHER ISSUES FROM OTHER PRODUCTS. IFU STATES THE FOLLOWING: TEST THE DEVICE FUNCTION PRIOR TO USE. IF THERE IS ANY SIGN OF MALFUNCTION, THE DEVICE SHOULD NOT BE USED AND RETURNED TO STRYKER FOR REPAIR EVALUATION. REPORTABILITY DECISION WAS CHECKED FOR CONSISTENCY. THE FAILURE(S) IDENTIFIED IN THE INVESTIGATION IS CONSISTENT WITH THE COMPLAINT RECORD. THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. MANUFACTURE DATE IS NOT KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1219942 FG SAFELIGHT FIBER OPTIC CABLE WITH ADVANCED IMAGING MODALITY 5 MM CONFOCAL OPTICAL IMAGING OWN STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown