BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFORM

    MDR report key: 22952851 · Received September 3, 2025

    Report

    Report Number
    2955842-2025-36605
    Event Type
    Injury
    Date Received
    September 3, 2025
    Report Date
    August 8, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GDW
    PMA / PMN Number
    K173721
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. STAPLER LOGS COULD NOT BE REVIEWED AS PROCEDURE DETAILS WERE NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER UNDERGOING DA VINCI-ASSISTED SURGICAL PROCEDURES, AN UNSPECIFIED NUMBER OF PATIENTS EXPERIENCED ANASTOMOTIC LEAKS. THE SURGEON HAD REPORTEDLY USED BLACK SUREFORM 60 RELOADS FOR BOWEL ANASTOMOSES. THE FOLLOWING INFORMATION IS UNKNOWN: THE EVENT/PROCEDURE DATES, WHAT MEDICAL INTERVENTION (IF ANY) WAS PERFORMED AS A RESULT OF THE COMPLICATIONS, THE PROCEDURE OUTCOMES, THE CAUSE OF THE COMPLICATIONS, AND THE CURRENT STATUSES OF THE PATIENTS INVOLVED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH A SURGEON FROM THE SITE TO GATHER ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. THE SURGEON INDICATED THAT THE COMPLICATIONS DID NOT APPEAR TO BE ASSOCIATED WITH ANY SPECIFIC SURGEON OR STAPLER INSTRUMENT/RELOADS IN GENERAL. FURTHERMORE, THE SURGEON INDICATED THAT THERE APPEARS TO BE MULTIPLE UNSPECIFIED FACTORS CONTRIBUTING TO THE LEAKS. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONALLY, ISI CONTACTED THE SITE'S ROBOTICS COORDINATOR TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. THE ROBOTICS COORDINATOR WAS NOT REPORTEDLY AWARE OF ANY CONFIRMED ANASTOMOTIC LEAKS OR INCIDENTS DIRECTLY RELATED TO SUREFORM 60 STAPLER INSTRUMENTS OR RELOADS, OR ANY OTHER ROBOTIC DEVICES. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2450587 SUREFORM STAPLER 60 RELOAD BLACK GDW INTUITIVE SURGICAL, INC 48360T UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other DA VINCI INSTRUMENTS AND ACCESSORIES