BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERI-STRIPS DRY WITH VERITASWITH SECURE GRIP

    MDR report key: 24552457 · Received March 9, 2026

    Report

    Report Number
    1416980-2026-00888
    Event Type
    Injury
    Date Received
    March 9, 2026
    Date of Event
    December 11, 2025
    Report Date
    March 9, 2026
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    OXE
    UDI-DI
    00085412658841
    PMA / PMN Number
    K213125
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    I WAS REPORTED THE PATIENT EXPERIENCED A GASTRIC SLEEVE LEAK IN CONJUNCTION WITH PERI-STRIPS. THE PATIENT UNDERWENT ROBOT-ASSISTED GASTRIC/BARIATRIC SURGERY WHERE A NON-BAXTER STAPLER AND HAD ¿GOOD RESULTS.¿ HOWEVER, THE GASTRIC LEAK WAS OBSERVED AND THE SURGEON SWITCHED TO A DIFFERENT NON-BAXTER SURGICAL STAPLER. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60854 PERI-STRIPS DRY WITH VERITASWITH SECURE GRIP MESH, SURGICAL, COLLAGEN, STAPLE LINE REINFORCEMENT OXE BAXTER HEALTHCARE CORPORATION PSDA60GIATHN NI 00085412658841

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other INTUITIVE SURGICAL STAPLER.| MEDTRONIC POWER STAPLER.