BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OERTLI SWITZERLAND

    MDR report key: 23696366 · Received December 2, 2025

    Report

    Report Number
    3013002167-2025-00001
    Event Type
    Injury
    Date Received
    December 2, 2025
    Report Date
    December 2, 2025
    Manufacturer
    VORTEX SURGICAL INC.
    Product Code
    HQB
    PMA / PMN Number
    K220263
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT NOT RETURNED FOR TESTING. ANALYSIS OF TESTING OF PRODUCT LOT SHOWS A PULL TEST OF 18 OZ WAS PERFORMED ON THE TIP OF THE PRODUCT PRIOR TO RELEASE. ENVISION AFRICA SHIPPED TWENTY (20), 23G LASER PROBE OS 4 ILLUMINATED FLEX-TIP DEVICES VK401213, HOWEVER IT IS UNLIKELY THAT ANY OF THESE WERE INVOLVED AS THE MOST RECENT NARRATIVE CONCLUDED IT WAS A 23G LASER PROBE OS 4 FLEX-TIP DEVICES VK401113 WHICH HAS NOT BEEN RETURNED AT THE TIME OF THIS REPORT. ADDITIONAL INFORMATION PROVIDED BY DISTRIBUTOR ON 11-14-2025: DESCRIPTION FROM ENVISION: THE PROBE TIP AND COLLAR BECAME LOOSE WHILE THE SURGEON WAS IN THE EYE. HE HAD NO CONTROL OVER THE DIRECTION THE TIP WAS POINTING BY MANIPULATING THE HAND-PIECE. THE SURGEON WAS LASERING AT THE 12 O'CLOCK POSITION AND LOST CONTROL DUE TO THE ABOVE, WHICH THEN RESULTED IN THE RETINA BEING DAMAGED. IT WAS A VK401213 23G ILLUMINATED FLEX TIP. - AMY THE ONLY FEEDBACK I HAVE IS THAT THE LASER TIP WAS BROKEN INSIDE THE HANDLE AND WAS NOT LOOSE. THE DOCTOR HAD ZERO CONTROL OVER THE DIRECTION OF THE LASER BECAUSE OF THIS AND WHEN THE LASER WAS INSERTED THROUGH THE PORT IT WAS IN THE WRONG DIRECTION AND TORE INTO THE RETINA. - DEAN PLEASE SEE THE ATTACHED PHOTOS FROM BOTH PROBES I RECEIVED. FROM THE PHOTOS YOU CAN SEE THE FRONT PART OF THE PROBE WHERE THE FIBRE IS INSTALLED, IS MISSING. I DID NOT SEE OR FIND ANY PARTS INSIDE THE PACKAGING, WHICH LEADS ME TO BELIEVE THAT THIS WAS LOST AFTER REMOVING THE PROBES FROM THE TROCARS OR THAT THIS WAS LOST IN TRANSPORT AS THE PACKAGES WERE JUST STAPLED CLOSED WITH LARGE GAPS. ONE PROBE WAS RECEIVED IN ITS PROTECTIVE PACKAGING WHILE THE SECOND PROBE WAS LOOSE IN THE BAG. TO PREVENT ANY FURTHER DAMAGE/LOSS I HAVE PACKAGED THE ITEMS INSIDE A STERI-REEL, AND PLACED THE ITEMS IN A BOX WITH SPONGE. OUR REFERENCE FOR THIS CASE IS: NC2025/4/026-VK401113 _ LASER PROBE OS 4, FLEX-TIP, 23G-INLAND LOT 2410031. ENVISION AFRICA VERBALLY NOTED CUSTOMERS UTILIZING DEVICE TO REACH 12 O'CLOCK HOUR LOCATION IN EYE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED REGARDING THE PATIENT OR USER. CUSTOMER UTILIZED DEVICE TO TREAT LOCATION OUTSIDE OF THE REACH OF THE PRODUCT UTILIZED BY TORQUING THE PRODUCT WITHIN THE EYE TO EXPAND THE REACH. PRODUCT NOT DESIGNED TO WITHSTAND EXCESSIVE FORCE OR TREAT LOCATIONS OUTSIDE OF 32.5 DEGREES CURVE OF THE DEVICE. 100% OF VORTEX SURGICAL LASER PROBES ARE PULL TESTED WITH AN 18OZ WEIGHT TO VERIFY STRENGTH PRIOR TO RELEASE. VORTEX SURGICAL HAS A 23GA INTUITIVE EXTENDABLE VK401323 WITH HAS THE ABILITY TO TREAT THE DESIRED LOCATION.

    Description of Event or Problem · 0

    ENVISION AFRICA (SOUTH AFRICA) NOTIFIED VORTEX SURGICAL THAT A USER OF THE 23G LASER PROBE OS4 ILLUMINATED FLEX-TIP VK401213 MISUSED THE PRODUCT DURING VITREORETINAL SURGERY. DURING THE SURGERY THE TIP BENT AND DR. LOST SIGHT OF IT AND POKED A HOLE IN THE RETINA. IT WAS LATER UPDATED THAT THE PROBE WAS A STANDARD 23G LASER PROBE OS4 FLEX-TIP VK401113, NOT THE ILLUMINATED VERSION ORIGINALLY NOTED. ENVISION AFRICA VERBALLY NOTED CUSTOMERS UTILIZING DEVICE TO REACH 12 O'CLOCK HOUR LOCATION IN EYE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED REGARDING THE PATIENT OR USER. CUSTOMER UTILIZED DEVICE TO TREAT LOCATION OUTSIDE OF THE REACH OF THE PRODUCT UTILIZED BY TORQUING THE PRODUCT WITHIN THE EYE TO EXPAND THE REACH. PRODUCT NOT DESIGNED TO WITHSTAND EXCESSIVE FORCE OR TREAT LOCATIONS OUTSIDE OF 32.5 DEGREES CURVE OF THE DEVICE. 100% OF VORTEX SURGICAL LASER PROBES ARE PULL TESTED WITH AN 18OZ WEIGHT TO VERIFY STRENGTH PRIOR TO RELEASE. VORTEX SURGICAL HAS A 23GA INTUITIVE EXTENDABLE VK401323 WITH HAS THE ABILITY TO TREAT THE DESIRED LOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1900734 OERTLI SWITZERLAND 23G LASER PROBE HQB VORTEX SURGICAL INC. VK401113 2410031

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other