BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFORM

    MDR report key: 15612445 · Received October 15, 2022

    Report

    Report Number
    2955842-2022-14607
    Event Type
    Injury
    Date Received
    October 15, 2022
    Date of Event
    September 12, 2022
    Report Date
    September 15, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GDW
    PMA / PMN Number
    K173721
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INSTRUMENT ACCESSORY INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. THE SUREFORM 60 BLUE RELOAD WAS RETURNED AND INSPECTION FOUND INDENTATIONS ON THE BLADE AT THE DISTAL END DUE TO MISHANDLING AND MISUSE. ADDITIONALLY, THE SUREFORM STAPLER 60 INSTRUMENT WAS RETURNED AND FAILURE ANALYSIS CONFIRMED NO FUNCTIONAL ISSUE WITH THE INSTRUMENT. A SYSTEM LOG REVIEW WAS PERFORMED BY THE INTUITIVE SURGICAL INC (ISI) REGULATORY POST MARKET SURVEILLANCE ANALYST AND CONFIRMED THAT THREE PROCEDURES WERE PERFORMED ON (B)(6) 2022. VERIFICATION OF THE ACCESSORY PRODUCT VIA SYSTEM LOGS COULD NOT BE PERFORMED BECAUSE ACCESSORY DEVICE PRODUCT DETAILS ARE NOT CAPTURED IN THE SYSTEM LOG. FURTHER REVIEW OF THE LOGS PERFORMED BY THE FAILURE ANALYSIS ENGINEER (FAE) CONFIRMED THAT A SUREFORM60 STAPLER INSTRUMENT WAS USED DURING THE (B)(6) 2022. NO IMAGE OR VIDEO OF THE PROCEDURE WAS PROVIDED FOR REVIEW. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE SUREFORM 60 STAPLE DID NOT CLOSE PROPERLY AND LOOSE STAPLE WAS NOTED. THE REPORT IS AMBIGUOUS AND IT IS LIKELY THAT THE STAPLES WERE MALFORMED WITH AN UNKNOWN CAUSE. 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. ADDITIONALLY, THE REPORTER WAS UNABLE TO CONFIRM IF A FRAGMENT FELL INSIDE THE PATIENT'S BODY. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE EVENT TO OCCUR. 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. THERE WAS NO REPORT OF PATIENT INJURY. AT THIS TIME IT IS UNKNOWN WHAT CAUSED THE BREAKAGE TO OCCUR. 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 AS UNINTENDED FRAGMENT(S) FALLING INTO THE PATIENT MAY REQUIRE SURGICAL INTERVENTION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: G3, G6, H2, H6, AND H10. ON (B)(6) 2022, THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED: THE SUREFORM STAPLER JAWS WERE NOT STUCK ON TISSUE WHEN THE ISSUE WAS IDENTIFIED. THERE WAS NO ADVERSE EFFECT TO THE GRASPED TISSUE, NO UNEXPECTED TISSUE REMOVAL AND NO UNEXPECTED BLEEDING. THE CUSTOMER ALSO EXPLAINED THERE WAS NO ISSUE WHEN TISSUE WAS BEING CLAMPED AND REMOVAL WAS NORMAL. IT IS UNKNOWN IF THERE WERE ANY MALFORMED STAPLES, BUT LOOSE STAPLES WERE NOTED. THERE WERE NO FRAGMENT(S) THAT FELL INTO THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN UNSPECIFIED DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SUREFORM 60 STAPLE ALLEGEDLY DID NOT CLOSE PROPERLY AND LOOSE STAPLE WAS NOTED. IT IS CURRENTLY UNKNOWN IF A FRAGMENT FELL INSIDE THE PATIENT'S BODY. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. THE REPORTER WAS UNABLE TO PROVIDE FURTHER INFORMATION RELATED TO THE PROCEDURE. INTUITIVE SURGICAL INC (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: INITIAL REPORTER STATED THAT THEY ARE UNABLE TO CONFIRM IF A STAPLER INSTRUMENT WAS USED INTRAOPERATIVELY. THE INITIAL REPORTER MENTIONED THAT THEY ARE UNABLE TO PROVIDE ANY FURTHER INFORMATION.

    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
    2744008 SUREFORM STAPLER 60 RELOAD BLUE GDW INTUITIVE SURGICAL, INC 48360B-08 NA

    Patients

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