BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUREFORM

    MDR report key: 21099203 · Received January 8, 2025

    Report

    Report Number
    2955842-2025-00177
    Event Type
    Malfunction
    Date Received
    January 8, 2025
    Date of Event
    June 18, 2024
    Report Date
    December 13, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874115647
    PMA / PMN Number
    K173721
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE SUREFORM 60 STAPLER INSTRUMENT WAS ANALYZED AND FOUND THE INSTRUMENT FAILED THE INITIALIZATION SEQUENCE DUE TO NOT DETECTING A VALID RELOAD AS INSTALLED AND COULD NOT BE TESTED FOR FIRING FUNCTIONALITIES. THE INSTRUMENT WAS DISASSEMBLED AND THE INSPECTION REVEALED THAT THE OUTER TUBE THAT IS SEATED OVER THE SLEEVE WAS DISPLACED. THIS DISPLACEMENT OF THE OUTER TUBE, LIKELY CONTRIBUTED TO THE BUNCHING AND SUBSEQUENT TEARING OF THE SLEEVE AND IS A RESULT OF A MANUFACTURING ERROR. FULL DISASSEMBLY REVEALED THAT THE I-BEAM SLEEVE BECAME BUNCHED AT THE OUTER SNAKE WRIST TUBE AND AT THE OPENING OF THE DISTAL CLEVIS CHANNEL. THE SLEEVE APPEARS TO HAVE BEEN TORN AND BECAME COMPRESSED AND BUNCHED DURING THE EXTENSION AND RETRACTION OF THE I-BEAM DURING USE. NO FRAGMENTS WERE OBSERVED OUTSIDE OF THE I-BEAM ASSEMBLY AND NO PIECES APPEAR TO BE MISSING.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE SUREFORM 60 STAPLER INSTRUMENT WAS ANALYZED AND FOUND TO THE INSTRUMENT'S I-BEAM SLEEVE TO BE DAMAGED. AS A RESULT, THE INSTRUMENT WAS UNABLE TO BE TESTED FOR ITS FIRING ABILITIES. PROCEDURE LOGS WERE UNABLE TO BE RETRIEVED DURING THIS TIME. ADDITIONAL OBSERVATION(S) RELATED TO CUSTOMER REPORTED COMPLAINT: THE INSTRUMENT WAS FOUND TO HAVE THE I-BEAM SLEEVE DAMAGED. A DISTAL INSERT WAS USED TO RETRACT THE I-BEAM, AND THE SLEEVE WAS FOUND TO BE DAMAGED. THE BEVEL SPUR GEAR WAS EXTREMELY HARD TO TURN. ADDITIONAL OBSERVATION(S) NOT REPORTED BY SITE: THE INSTRUMENT WAS FOUND TO HAVE RELOAD PIECES LODGED IN JAWS. A TWEEZER WAS USED TO REMOVE THE BROKEN PIECES, AND TWO WERE CONFIRMED. THE INSTRUMENT WAS PLACED ON AN IN-HOUSE SYSTEM AND DISPLAYED ERROR MESSAGE "MISSING OR USED RELOAD. REMOVE INSTRUMENT AND INSTALL A NEW RELOAD". THE SAME RELOAD WAS TESTED IN AN IN-HOUSE GOLDEN INSTRUMENT AND PASSED THE RELOAD RECOGNITION TEST. THE BROKEN PIECES IN THE JAWS LIKELY CAUSED THE ERROR. THE COMPLAINT REGARDING THE STAPLER BLADE EXPOSED WAS CONFIRMED BY FAILURE ANALYSIS.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE SUREFORM 60 STAPLER MISFIRED AND LEFT THE BLADE EXPOSED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1106005 SUREFORM STAPLER 60 NAY INTUITIVE SURGICAL, INC 480460-09 T11230315 0156 10886874115647

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES