BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFORM

    MDR report key: 16076128 · Received December 29, 2022

    Report

    Report Number
    2955842-2022-16209
    Event Type
    Injury
    Date Received
    December 29, 2022
    Date of Event
    February 22, 2023
    Report Date
    November 30, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K183224
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A RETURN MATERIAL AUTHORIZATION (RMA) HAS BEEN ISSUED AND INTUITIVE SURGICAL, INC. (ISI) HAS REQUESTED TO HAVE THE SUREFORM STAPLER 45 BE RETURNED FOR EVALUATION; HOWEVER, THE INSTRUMENT HAS NOT YET BEEN RECEIVED AS OF THE DATE OF THIS REPORT. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/OR IF ADDITIONAL INFORMATION IS RECEIVED. ADVANCED FAILURE ANALYSIS ENGINEER (AFAE) REVIEW WAS PERFORMED AND OBTAINED THE FOLLOWING INFORMATION: LOGS SHOWED TWO SUREFORM STAPLER 45S WERE USED FOR THIS PROCEDURE. - FIRST STAPLER USED WAS PART #480445-04, LOT #T91220422-0315 AND IT WAS INSTALLED ON THE SYSTEM 5X AND FIRED 5 RELOADS (ALL GREEN). THIS INSTRUMENT HAD 16 INCOMPLETE CLAMPS OUT OF 21 ATTEMPTS ACROSS ALL INSTALLS. INCOMPLETE CLAMP COMPLETION PERCENTAGES RANGED FROM ~56% TO ~76%. ON INSTALL 1, FIRING WAS COMPLETED WITH NO PAUSES FOR COMPRESSION. ON INSTALL 2, FIRING WAS COMPLETED WITH 1 PAUSE FOR COMPRESSION. ON INSTALL 3, FIRING WAS COMPLETED WITH 4 PAUSES FOR COMPRESSION. ON INSTALL 4, FIRING WAS COMPLETED WITH 3 PAUSES FOR COMPRESSION. ON THE LAST INSTALL, THERE WERE 4 INCOMPLETE CLAMP ATTEMPTS WITH THE 5TH CLAMP COMPLETED SUCCESSFULLY. FOLLOWING THE COMPLETED CLAMP, THERE WAS A FIRING FAILURE, STOPPING AT ~83% COMPLETION. THE FIRING FAILED AFTER A DURATION OF ~46 SECONDS. - NEXT, THE LOGS SHOWED PART #480445-04, LOT #T12220526-0018 WAS INSTALLED ON THE SYSTEM 1X AND FIRED 1 GREEN RELOAD WITH 1 PAUSE FOR COMPRESSION. THERE WERE NO INCOMPLETE CLAMPS, INCOMPLETE UNCLAMPS, OR FIRING FAILURES FOR THIS INSTRUMENT. THERE WERE NO STAPLER RELATED ERRORS IN THE MSC LOGS FOR THIS PROCEDURE. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE STAPLER STOPPED WORKING MID-STAPLE AND THE RELOAD COULD NOT BE REMOVED FROM THE STAPLER INSTRUMENT. MISSING STAPLES DUE TO INCOMPLETE STAPLING MAY CONTRIBUTE TO AN INCOMPLETE STAPLE LINE. IF NOT RECOGNIZED DURING THE PROCEDURE, MEDICAL INTERVENTION, INCLUDING ADDITIONAL SURGICAL PROCEDURES, MAY BE REQUIRED IN THE EVENT THAT THE STAPLES ARE NOT DELIVERED FROM THE RELOAD. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE EVENT TO OCCUR.

    Additional Manufacturer Narrative · 0

    THE SUREFORM 45 STAPLER ASSOCIATED WITH THIS EVENT AND THE GREEN RELOAD USED IN CONJUNCTION WITH THE STAPLER WERE BOTH RETURNED TO INTUITIVE SURGICAL, INC., AND EVALUATED BY THE FAILURE ANALYSIS TEAM ON 02/01/2023. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED BUT DID NOT REPLICATE THE CUSTOMER REPORTED COMPLAINT. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF FIRING FAILURE BASED ON LOG REVIEW TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. REVIEW OF LOGS REVEALED ONE PARTIAL FIRE DURING FIFTH INSTALL WITH A GREEN RELOAD. THE GREEN RELOAD WAS FOUND TO HAVE A KNIFE EXPOSED WITHIN THE KNIFE TRACK WHICH WAS RELATED TO FIRING FAILURE OBSERVED IN THE LOGS. COMMON CAUSES OF THE FAILURE MODE EXPOSED COMPONENT RELOAD ARE TYPICALLY ATTRIBUTED TO THE USER. EXAMPLE: FIRING ACROSS A STAPLE LINE OR OTHER OBSTRUCTIONS. ADDITIONAL OBSERVATIONS NOT REPORTED BY SITE THAT ARE RELATED TO THE PRIMARY FAILURE: THE RELOAD WAS FOUND TO HAVE DAMAGE TO THE KNIFE BLADE. COMMON CAUSE OF THIS FAILURE IS ATTRIBUTED TO THE USER. THE RELOAD WAS FOUND TO HAVE CARTRIDGE DAMAGE. BROKEN PIECES APPROXIMATELY 0.026" X 0.077" IN SIZE WERE RETURNED WITH THE RELOAD BUT UNABLE TO DETERMINE IF IT WAS ALL THE BROKEN PIECES. COMMON CAUSE OF THIS FAILURE IS ATTRIBUTED TO THE USER. THE COMPLAINT REGARDING SUREFORM STAPLER 45 STOPPED WORKING DURING MID- STAPLE WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2023, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE SECOND SUREFORM 45 STAPLER INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. THE FAILURE ANALYSIS WAS CONDUCTED UNDER RMA #300690300010 (PR583004). FAILURE ANALYSIS (FA) INVESTIGATION CONFIRMED THE CUSTOMER REPORTED COMPLAINT ¿SUREFORM STAPLER 45 STOPPED WORKING DURING MID- STAPLE¿. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF FAILED ENGAGEMENT TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE MULTIPLE ENGAGEMENT FAILURES BASED ON LOG REVIEW. THE MSC LOGS DISPLAYED SIX "ROLL AXIS HARDSTOP" ENGAGEMENT FAILURES WITH P3=537919482 ERROR CODE AND DESCRIPTION "INSTALLED SUREFORM 45 STRAIGHT-TIP FAILED TO ENGAGE ON USM2". THE INSTRUMENT WAS PLACED ON AN IN-HOUSE SYSTEM AND FAILED ENGAGEMENT ON 3 OUT OF 3 ATTEMPTS. THE IN-HOUSE SYSTEM DISPLAYED ERROR CODE "22020" WITH "P3=200FFFFA" WHICH INDICATED A ROLL HARDSTOP ENGAGEMENT FAILURE. THE ROOT CAUSE IS ATTRIBUTED TO ROLL BUSHING. FAILURE ANALYSIS FOUND THE SECONDARY FAILURE OF ROLL BUSHING BINDING TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE ROLL BUSHING BETWEEN THE ROLL GEAR AND THE MAIN BUSHING. THE BINDING IS LIKELY CAUSED BY THE ID BEING OUT OF SPEC (TOO SMALL) WHICH IS LIKELY CAUSING INCREASED ROLL FRICTION. THE INSTRUMENTS MAIN TUBE WAS MANUALLY ROTATED, AND HIGH FRICTION WAS OBSERVED. THE PROBABLE ROOT CAUSE OF THIS ROLL BUSHING BINDING FAILURE IS ATTRIBUTED TO MANUFACTURING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION (LAR), THE SUREFORM STAPLER 45 STOPPED WORKING MID-STAPLE, AND THE RELOAD WAS UNABLE TO BE REMOVED FROM THE STAPLER. IT WAS UNKNOWN HOW THE STAPLING TASK WAS COMPLETED. THE PROCEDURE WAS OTHERWISE COMPLETED WITH NO REPORTED INJURY. MULTIPLE FOLLOW-UP ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER CONCERNING THE REPORTED EVENT WITH NO SUCCESS.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2824889 SUREFORM SUREFORM 45 RELOAD GREEN NAY INTUITIVE SURGICAL, INC 48345G N/A
    478799 SUREFORM SUREFORM 45 RELOAD GREEN NAY INTUITIVE SURGICAL, INC 48345G N/A

    Patients

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