BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFORM

    MDR report key: 15325627 · Received August 31, 2022

    Report

    Report Number
    2955842-2022-13762
    Event Type
    Injury
    Date Received
    August 31, 2022
    Date of Event
    August 1, 2022
    Report Date
    August 1, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GDW
    UDI-DI
    10886874117115
    PMA / PMN Number
    K183224
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE SUREFORM 45 BLACK RELOAD ACCESSORY ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INITIAL INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATIONS REPLICATED AND CONFIRMED THE CUSTOMER REPORTED COMPLAINT. FAILURE ANALYSIS FOUND THE PRIMARY OF MALFORMED STAPLES TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. FOR CLARIFICATION, THE ACCESSORY RELOAD EXHIBITED A MALFORMED STAPLE WITHIN THE CARTRIDGE. ALTHOUGH THE STAPLE WAS LODGED WITHIN, THE RELOAD SUCCESSFULLY FIRED COMPLETELY. ALL THE PUSHERS HAD DEPLOYED ON THE CARTRIDGE. THE ROOT CAUSE FOR THE MALFORMED STAPLES IS NOT ESTABLISHED. ADDITIONAL OBSERVATIONS NOT REPORTED BY SITE INCLUDE THAT THE RELOAD BLADE WAS FOUND TO HAVE MECHANICAL INDENTATION DAMAGE. NO MATERIAL WAS MISSING. THE ROOT CAUSE OF THE BLADE DAMAGE IS ATTRIBUTED TO MISUSE. THE RELOAD WAS TRANSFERRED TO ENGINEERING FOR FURTHER REVIEW. THE PRODUCT ASSOCIATED WITH THIS EVENT IS A SUREFORM RELOAD AND CANNOT BE IDENTIFIED BY THE INSTRUMENT LOGS. AS A RESULT, A TOOL USAGE LOG COULD NOT BE PERFORMED TO DETERMINE WHEN THE RELOAD WAS USED. NO IMAGE OR VIDEO OF THE PROCEDURE WAS PROVIDED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE STAPLES WERE MALFORMED. MALFORMED STAPLES 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 FORMED AS EXPECTED. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. HAS RECEIVED THE SUREFORM STAPLER 45 RELOAD ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INITIAL INVESTIGATIONS. VISUAL INSPECTION SHOWED DISTAL END OF CARTRIDGE KNIFE SLOT EXHIBITED DAMAGE, LIKELY CAUSED BY LODGED STAPLES BEING DRAGGED AS KNIFE WAS RETRACTING DURING THE END OF THE FIRING PROCESS. CARTRIDGE DAMAGE, ALONG WITH KNIFE DAMAGE ARE LIKELY RELATED TO LODGED STAPLES, WHICH WERE LIKELY CAUSED BY FIRING ACROSS A PRIOR STAPLE LINE. ALL VISIBLE DAMAGE ON RELOAD IS LIKELY A RESULT OF USER FIRING ACROSS PRIOR STAPLE LINE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE LAST COUPLE OF ROWS OF STAPLES GOT STUCK HALF-WAY BETWEEN THE STAPLE LINE AND RELOAD. THE PROCEDURE WAS COMPLETING AS PLANNED 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 THE DATE OF THIS REPORT.

    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
    2614860 SUREFORM SUREFORM 45 RELOAD BLACK GDW INTUITIVE SURGICAL, INC 48345T-01 T90220203 10886874117115

    Patients

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