BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFORM

    MDR report key: 24442020 · Received February 25, 2026

    Report

    Report Number
    2955842-2026-08442
    Event Type
    Injury
    Date Received
    February 25, 2026
    Date of Event
    January 26, 2026
    Report Date
    April 14, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GDW
    UDI-DI
    10886874117580
    PMA / PMN Number
    K183224
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION/DEVICE EVALUATION: INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE SUREFORM STAPLER INVOLVED WITH THE EVENT; HOWEVER, THE FAILURE ANALYSIS EVALUATION HAS NOT BEEN COMPLETED. FAILURE ANALYSIS WAS COMPLETED ON THE UNIVERSAL SURGICAL MANIPULATOR (USM) ARM (PART NO. 380647-33, SERIAL NO. (B)(6). THE USM WAS RETURNED FOR EVALUATION FOLLOWING A REPORTED ERROR. THIS ERROR WAS CONFIRMED BUT COULD NOT BE REPLICATED DURING TESTING. THE ERROR REFLECTS A ¿CANNULA SENSOR ERROR¿, CONFIRMING THAT THE FAULT WAS PRESENT IN THE FIELD. VISUAL INSPECTION REVEALED NO ISSUES RELATED TO THE REPORTED EVENT. THE USM WAS INSTALLED ONTO A TESTING PLATFORM, WHERE ALL RELEVANT TESTING WAS PASSED WITHIN SPECIFICATION. SUBSEQUENT INSPECTION OF THE CANNULA PRINTED CIRCUIT ASSEMBLY (PCA) DID NOT REVEAL ANY FAULTS. BASED ON THESE FINDINGS, FAILURE ANALYSIS CONCLUDED THAT THE CANNULA PCA IS CONSISTENT WITH THE REPORTED EVENT AND MAY BE A POTENTIAL CAUSE OF THE ISSUE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC (ISI) DID NOT RECEIVE THE STAPLER TO PERFORM FAILURE ANALYSIS. A REMOTE LOG REVIEW BY INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) IDENTIFIED SENSOR ISSUES WITH UNIVERSAL SURGICAL MANIPULATOR (USM) 4 AND USM1. USM 4 WAS REPLACED BY AN ISI FIELD SERVICE ENGINEER (FSE) AFTER REPRODUCING THE ISSUE. USM1'S ERROR WAS RESOLVED AFTER A RESTART. THE SURGEON SIDE CONSOLE ARMREST WAS ALSO REPLACED DUE THE CUSTOMER NOTING PERSISTENT ISSUES WITH DELAYED FINGER CLUTCH RESPONSE WHICH WAS ABLE TO BE WORKED THROUGH BY USING THE FOOT SWITCH INSTEAD OF THE HAND SWITCH. THE SYSTEM WAS VERIFIED AS READY FOR USE. MOISTURE FOLLOWING CLEANING WAS SUSPECTED AS A CONTRIBUTING FACTOR. ADDITIONAL TRAINING IN DEVICE CLEANING AND USE OF THE INSTRUMENT RELEASE KEY WAS GOING TO BE PROVIDED TO THE CUSTOMER. A LOG REVIEW WAS PERFORMED THE DATA SHOWED THAT THE SUREFORM 45 INSTRUMENT PART NO 480445-06, LOT NO L15250213-0057, WAS INSTALLED ON THE SYSTEM 4 TIMES AND FIRED 4 RELOADS (3 BLUE, FOLLOWED BY 1 WHITE). ON EACH INSTALL, ALL CLAMPS WERE SUCCESSFUL, AND THE STAPLER FIRES WERE COMPLETED WITH NO PAUSES FOR COMPRESSION. THE FINAL UNCLAMP WAS SHOWN AS SUCCESSFUL, HOWEVER APPROXIMATELY 1 MINUTE LATER, THE EMERGENCY STOP BUTTON WAS PRESSED BY THE USER ON SURGEON SIDE CONSOLE. USE OF THE E-STOP IS REPRESENTED BY AN ERROR CODE. SHORTLY AFTER USING THE E-STOP, ANOTHER ERROR APPEARED, INDICATING THE USE OF GRIP RELEASE TOOL WAS DETECTED ON THE INSTRUMENT, WHICH RESULTED IN THE FORCE EXPIRATION OF THE INSTRUMENT BY THE SYSTEM. THE INSTRUMENT WAS REMOVED AND NOT USED IN THE PROCEDURE AGAIN. THERE WERE NO ADDITIONAL STAPLER-RELATED ERRORS IN THE LOGS.

    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 TRANSTHORACIC ESOPHAGECTOMY WITH CHEST ANASTOMOSIS SURGICAL PROCEDURE, THE UNIVERSAL SURGICAL MANIPULATOR (USM) 4 ARM MALFUNCTIONED WITH A SUREFORM 45 STAPLER INSTALLED, CAUSING THE INSTRUMENT JAWS TO BECOME STUCK ON TISSUE AND PREVENTING RELEASE. AN ERROR MESSAGE WAS DISPLAYED. TECHNICAL SUPPORT IDENTIFIED ARM CANNULA SENSOR ERRORS. THE INSTRUMENT RELEASE KEY WAS ABLE TO BE SUCCESSFULLY USED FOR THE FIRST STAPLER, RENDERING THAT INSTRUMENT UNUSABLE. A BACKUP STAPLER WAS THEN USED, BUT THE ISSUE RECURRED, REQUIRING THE SURGEON TO CUT TISSUE AROUND THE JAWS FOR REMOVAL AND TO BE OPENED OUTSIDE OF THE BODY. NO FRAGMENTS REMAINED IN THE PATIENT, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED ROBOTICALLY WITH ALL FOUR ARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507515 SUREFORM SUREFORM 45 GDW INTUITIVE SURGICAL, INC 480445-06 L15250213 0057 10886874117580

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES.