BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PKG F88 FLEXIBLE URETEROSCOPE STANDARD

    MDR report key: 23174865 · Received September 29, 2025

    Report

    Report Number
    0002936485-2025-00806
    Event Type
    Injury
    Date Received
    September 29, 2025
    Date of Event
    September 2, 2025
    Report Date
    December 1, 2025
    Manufacturer
    SG ENDOSCOPY PTE LTD
    Product Code
    FGB
    UDI-DI
    08881300750084
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RECEIVED FOR EVALUATION AT STRYKER ENDOSCOPY. THE DEVICE WAS RECEIVED AT SG-ENDOSCOPY FOR EVALUATION. BASED ON THE SG REPORT, THE REPORTED FAILURE: "BROKE DURING CASE" WAS CONFIRMED. ACCORDING TO SG: FAILURE ANALYSIS: A VISUAL ANALYSIS ON THE CAMERA HOUSING AND DISTAL TIP WAS PERFORMED, THE COMPLAINT DESCRIPTION "TORE OFF THE CAMERA ITSELF" WAS NOT CONFIRMED AS THERE WAS NO DAMAGE OBSERVED ON THE TIP NOR ON THE CAMERA LENS UNDER 1 OX MAGNIFICATION. THE LOCATION OF THE BREACH WAS MEASURED TO BE ABOUT 3 MM IN DIAMETER AND ABOUT 570 MM AWAY FROM THE DISTAL TIP. THE LENGTH OF THE LASER FIBER WAS ALSO MEASURED TO BE SL SLIGHTLY MORE THAN 570 MM. WHEN PLACED SIDE BY SIDE, THE PROXIMAL END OF THE LASER FIBER WAS FOUND TO TERMINATE AT THE SAME LOCATION AS THE BREACH AT THE INSERTION TUBE. FURTHER VISUAL INSPECTION UNDER A 1 OX MAGNIFICATION OF THE BREAK LOCATION REVEALED SIGNS OF MATERIAL MELTING AND BURN MARKS. THIS IS EVIDENT OF LASER DAMAGE. THE DEVICE WAS CONNECTED TO A CAMERA CONTROL UNIT TO CHECK FOR IMAGE AND LIGHT FUNCTIONALITY. DEVICE WAS ABLE TO BE POWERED ON WITHOUT ISSUE, IMAGE TRANSMISSION TO DISPLAY MONITOR ALSO WORKED AS NORMAL. THE ILLUMINATION OF THE SUBJECT DEVICE WAS THEN MEASURED VIA A TES-133 LUMINOUS FLUX METER (MET-0085) TO BE 0.017 IM, THIS IS LARGELY DIMIN WHEN COMPARING TO THE VALUES OBTAINED FROM THE DEVICE HISTORY RECORD (OHR) OF THE DEVICE (MEASURED AT 9.274 IM). IN ADDITION, LIGHT WAS EMITTED FROM THE HOLE AT THE INSERTION TUBE, INDICATING THAT THE REDUCTION IN ILLUMINATION IS DUE TO THE DAMAGE OF THE LIGHT GUIDE. ADDITIONAL INFORMATION WAS SUBSEQUENTLY OBTAINED FROM THE IMPORTER, STATING THAT THE DEVICE WAS USED IN A COMPLICATED PCNL PROCEDURE TO OBSERVE THE BLADDER USING MULTIPLE COMPETITOR SCOPES. AL L SCOPES USED WERE DAMAGED BEFORE THE SUBJECT DEVICE WAS USED, AND DUE TO CHALLENGING ANGLE AND EXCESSIVE FORCE, THE ACCESS SHEATH SNAPPED, AND THIS IN TURN DAMAGED THE DEVICE. A REVIEW OF THE PRA-001 AND FMEA-002 (APPLICATION-PROCEDURE) WAS PERFORMED, EXCESSIVE FORCE ON THE SCOPE HAD PREVIOUSLY BEEN ACCESSED AND THE EFFECT WAS LISTED AS DAMAGE TO DEVICE, AND POSSIBLY LEADING TO LIQU ID INGRESS WHICH MAY REDUCE THE EFFECTIVENESS OF REPROCESSING, ULTIMATELY LEADING TO PATIENT INFECTION (SEVERITY LEVEL 3). RISK CONTROL MEASURES HAVE ALREADY BEEN TAKEN IN THE FORM OF WARNINGS IN THE IFU WHICH STATES THAT "DO NOT APPLY EXCESSIVE FORCE ON ANY PART OF THE INSERTION PORTION". CONCLUSION: FROM THE INVESTIGATION ABOVE, THE COMPLAINT DESCRIPTION ON THE "TORE OFF CAMERA ITSELF' IS UNCONFIRMED. A BREAK WAS OBSERVED ON THE INSERTION PORTION, AND THE MOST PROBABLE ROOT CAUSE OF THE MALFUNCTION IS SUSPECTED TO BE DUE TO USE ERROR WHERE THE USER HAD EXERTED EXCESSIVE FORCE ON THE DEVICE. A BREAK IN THE UPPER HALF OF THE INSERTION TUBE IS NOT EXPECTED TO HAPPEN DURING NORMAL USE. A POSSIBLE PROGRESSION OF THE EVENT IS THAT WHILE THE SURGEON WAS OPERATING A LASER FIBER, THE OUTER ACCESS SHEATH WAS BROKEN DUE TO EXCESSIVE FORCE, THIS IN TURN KINKED THE URETEROSCOPE AND THE LASER FIBER WITHIN, CAUSING LASER DAMAGE LEADING TO THE MELTING OF THE MATERIAL AND THE DAMAGE AS OBSERVED. PLANNED CORRECTIVE AND/OR PREVENTIVE ACTIONS FOR THE DAMAGE ARE AS FOLLOWS: INFORM DISTRIBUTOR OF SUSPECTED ROOT CAUSE AND TO REMIND USER TO USE THE DEVICE AS STATED IN THE IFU. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMAGE WAS LOST DURING THE PROCEDURE WHICH CONTRIBUTED TO THE PROCEDURE NOT BEING ABLE TO BE COMPLETED AND HAVING TO BE RESCHEDULED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMAGE WAS LOST DURING THE PROCEDURE WHICH CONTRIBUTED TO THE PROCEDURE NOT BEING ABLE TO BE COMPLETED AND HAVING TO BE RESCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1663884 PKG F88 FLEXIBLE URETEROSCOPE STANDARD URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FGB SG ENDOSCOPY PTE LTD 08881300750084

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other