BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFORM

    MDR report key: 14849293 · Received June 29, 2022

    Report

    Report Number
    2955842-2022-12528
    Event Type
    Injury
    Date Received
    June 29, 2022
    Date of Event
    February 18, 2020
    Report Date
    March 9, 2020
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GDW
    UDI-DI
    10886874115647
    PMA / PMN Number
    K173721
    Removal / Correction Number
    ISIFA2022-02-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE SUREFORM STAPLER 60 INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED DEVICE EVALUATION. FAILURE ANALYSIS (FA) COULD NOT REPLICATE NOR CONFIRM THE CUSTOMER REPORTED COMPLAINT. SQL LOGS WERE REVIEWED AND NO FAILURES WERE FOUND. THE SUREFORM STAPLER INSTRUMENT WAS TESTED IN HOUSE AND HAD NO ISSUES WITH INITIALIZATION, CLAMPING, FIRING, AND UNCLAMPING. ADDITIONAL FINDINGS NOT REPORTED BY THE SITE: THE MAINTUBE EXHIBITED FRICTION AND WAS DIFFICULT TO ROTATE, THE HOUSING WAS REMOVED AND FOUND CORROSION ON THE BEARINGS. THE KNOWN COMMON CAUSE OF THIS FAILURE IS IMPROPER CLEANING. THE INSTRUMENT WAS RE-TESTED ON SYSTEM AND NON-INTUITIVE MOTION WAS CONFIRMED. PITCH/YAW OUTPUT MOTION AT DISTAL END WAS OPPOSITE FROM INPUT MOTION AT MASTERS. GRIP OPEN/CLOSE FUNCTION WAS INTUITIVE. HIGH ROLL AXIS FRICTION WAS CONFIRMED. INSTRUMENT WAS DISASSEMBLED AND THE ROLL THRUST BEARING WAS FOUND TO EXHIBIT HEAVY CORROSION, SUCH THAT THE ROLLERS BECAME SEIZED. CORRODED ROLL BEARING IS THE CAUSE OF HIGH ROLL FRICTION AND NON-INTUITIVE MOTION. CORROSION MAY POSSIBLY BE A RESULT OF SALINE OR OTHER LIQUID COMING INTO CONTACT WITH BEARINGS. ISI HAS ALSO RECEIVED THE BLUE SUREFORM 60 STAPLER RELOAD ASSOCIATED WITH THIS COMPLAINT AND FAILURE ANALYSIS WAS PERFORMED. NO FAILURE REPORTED. VISUAL INSPECTION WAS CONDUCTED, AND NO DAMAGE FOUND. THE RELOAD WAS NOT FIRED. NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. A REVIEW OF THE SYSTEM LOGS FOR THE EVENT DATE OF 18-FEB-2020 HAS BEEN PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) FAILURE ANALYSIS ENGINEER (FAE) AND THE FOLLOWING WAS OBSERVED: THERE WERE NO OBSERVED EVENTS IN THE SYSTEM LOGS THAT WOULD SUGGEST A PRODUCT ISSUE AND THE LOGGED EVENTS ARE IN LINE WITH NORMAL SYSTEM FUNCTIONALITY. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING THE ATTEMPT TO PERFORM RECONSTRUCTION, THE INITIAL REPORTER CLAIMED THAT THE JAWS OF THE STAPLER INSTRUMENT WOULD NOT COMPLETELY CLOSE. THE SURGEON THEN MADE THE DECISION TO CONVERT TO A LAPAROTOMY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROXIMAL GASTRECTOMY PROCEDURE, A BLUE SUREFORM STAPLER 60 RELOAD WAS FIRED WITH A SUREFORM STAPLER 60 INSTRUMENT. THE STAPLER RELOAD WAS FIRED DURING RECONSTRUCTION BY THE ¿SOFY METHOD.¿ WHILE CLOSING THE COMMON HOLE, THE SURGEON MADE THE DECISION TO CUT THE ESOPHAGUS AGAIN AND TRY ¿RECONSTRUCTION WITH DOUBLE TRACT.¿ AT THE TIME THE COMPLAINT WAS INITIALLY REPORTED, IT WAS UNKNOWN WHY THE SURGEON DECIDED TO PERFORM RECONSTRUCTION OF THE ANASTOMOSIS. DURING THE ATTEMPT TO PERFORM RECONSTRUCTION, THE INITIAL REPORTER CLAIMED THAT THE JAWS OF THE STAPLER INSTRUMENT WOULD NOT COMPLETELY CLOSE. THE SURGEON THEN MADE THE DECISION TO CONVERT TO A LAPAROTOMY. THE SURGEON COMMENTED THAT THE EVENT MIGHT HAVE BEEN A "TECHNICAL PROBLEM." ON 02-MAR-2020, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: DURING THE ¿RESIDUAL GASTRIC ANASTOMOSIS OF THE ESOPHAGUS,¿ THE SURGEON FIRED THE STAPLER INSTRUMENT. THERE WERE NO REPORTED ISSUES RELATED TO FIRING THE STAPLER INSTRUMENT. WHILE CLOSING THE COMMON HOLE, THE SURGEON NOTICED AN UNSPECIFIED ABNORMALITY WITH THE ANASTOMOSIS. THEREFORE, THE SURGEON CUT THE ESOPHAGUS AGAIN AND RECONSTRUCTED THE ANASTOMOSIS WITH A ¿DOUBLE TUBE.¿ WHILE USING THE SUREFORM STAPLER 60 INSTRUMENT, THERE WERE WAS NO TISSUE TENSION OR BUNCHING. ADDITIONALLY, THERE WERE NO CLAMPING, FIRING, OR UNCLAMPING ISSUES WITH THE STAPLER INSTRUMENT. A STAPLE LINE DEFECT WAS NOT IDENTIFIED. THERE WERE NO MALFORMED OR MISSING STAPLES. IN ADDITION, NO STAPLING RELATED ERRORS WERE REPORTED. ON 08-MAR-2020, AN ISI SAFETY CONTROL SPECIALIST (SCS), PROVIDED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: "THERE IS NO MISSING/MALFORMED STAPLES AND NO HOLE ON THE STAPLE LINE. SINCE THE FIRE WAS PERFORMED UNDER THE CONDITIONAL WHICH THE ANVIL ROD INSERTED BETWEEN THE SEROSA AND THE MUCOSA OF THE ESOPHAGUS, ALL TISSUE LAYERS OF THE ESOPHAGEAL WALL COULD NOT BE SUTURED PROPERLY." IN REGARDS TO THE CAUSE OF THE ABNORMALITY OF THE ANASTOMOSIS, THE SURGEON REPORTEDLY COMMENTED THAT IT WAS "INDUCED BY FIRE UNDER THE CONDITIONAL WHICH THE ANVIL ROD INSERTED BETWEEN THE SEROSA AND THE MUCOSA OF THE ESOPHAGUS¿. HOWEVER, THE SITE BELIEVES THE STAPLER INSTRUMENT MALFUNCTIONED. IT IS UNCLEAR HOW THE ANASTOMOSIS WAS RECONSTRUCTED VIA OPEN SURGERY. ON 3-JUN-2020, THE ISI SCS, PROVIDED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: WHEN THE SURGEON STATED ¿THIS MAY BE A TECHNICAL PROBLEM¿, THE SITE CLARIFIED THAT THIS WAS MEANT AS AN ISSUE WITH SURGICAL TECHNIQUE. THE ABNORMALITY OF THE ANASTOMOSIS WAS THAT ALL TISSUE LAYERS OF THE ESOPHAGEAL WALL COULD NOT BE SUTURED PROPERLY SINE THE STAPLER FIRE WAS PERFORMED UNDER THE CONDITIONAL WHICH THE ANVIL ROD INSERTED BETWEEN THE SEROSA AND THE MUCOSA OF THE ESOPHAGUS. THE ANASTOMOSIS NEEDED TO BE PERFORMED AGAIN BECAUSE ONLY THE SEROSA WAS STAPLED INSTEAD OF FULL OF THE ESOPHAGUS'S LAYER. IT'S UNKNOWN WHETHER ANY ADDITIONAL TISSUE WAS REQUIRED TO BE CUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705136 SUREFORM SUREFORM STAPLER 60 GDW INTUITIVE SURGICAL, INC 480460-08 L92191014 10886874115647

    Patients

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