BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUREFORM

    MDR report key: 17102180 · Received June 10, 2023

    Report

    Report Number
    2955842-2023-16148
    Event Type
    Malfunction
    Date Received
    June 10, 2023
    Date of Event
    March 2, 2023
    Report Date
    May 11, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GDW
    UDI-DI
    10886874121921
    PMA / PMN Number
    K211997
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE TECH COULD NOT LOAD THE SUREFORM 30 STAPLER WHITE RELOAD ONTO THE STAPLER, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE STAPLER RELOAD INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION REPLICATED AND CONFIRMED THE CUSTOMER REPORTED COMPLAINT ¿RELOADS BROKE BEFORE USE¿. VISUAL INSPECTION OF THE RELOAD FOUND THE "WING" AT THE PROXIMAL END OF THE RELOAD WAS BREAKING OFF AND TWISTED. ADDITIONAL FINDINGS INDICATED THAT THE RELOAD HAD NOT BEEN FIRED AT ALL. NO PUSHERS OF THE STAPLES WERE FOUND AT THE BED SURFACE OF THE CARTRIDGE. THE COMPLAINT REGARDING THE RELOADS BROKE BEFORE USE WAS CONFIRMED BY FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER COULD NOT LOAD THE SUREFORM 30 STAPLER WHITE RELOAD ONTO THE STAPLER INSTRUMENT. AS REPORTED, THE RELOAD BROKE BEFORE USE. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) HAS MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL PATIENT/EVENT INFORMATION. HOWEVER, DESPITE THE GOOD FAITH EFFORTS NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453123 SUREFORM 8MM STAPLER GDW INTUITIVE SURGICAL, INC 48230W-02 U90220518 10886874121921

    Patients

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