BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFORM

    MDR report key: 14859967 · Received June 29, 2022

    Report

    Report Number
    2955842-2022-12556
    Event Type
    Injury
    Date Received
    June 29, 2022
    Date of Event
    February 16, 2022
    Report Date
    February 22, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GDW
    PMA / PMN Number
    K183224
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE CUSTOMER REPORTED COMPLICATION CANNOT BE DETERMINED. THE STAPLER RELOAD IS NOT EXPECTED TO BE RETURNED AS IT WAS DISCARDED BY THE FACILITY. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. A REVIEW OF THE SYSTEM LOG WAS PERFORMED. PER THE REVIEW, THE FOLLOWING WAS CONFIRMED: SYSTEM SERIAL #, EVENT DATE, CONSOLE SURGEON AND PROCEDURE NAME/CATEGORY. A REVIEW OF THE INSTRUMENT LOG FOR THE SUREFORM 45 STAPLER (PN: 480545-4, BATCH-SEQ: T90200923-0081) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE WAS LAST USED ON 16-FEBRUARY-2022 ON SYSTEM SK1127. SUREFORM STAPLERS ARE SINGLE USE INSTRUMENTS. A REVIEW OF THE INSTRUMENT LOG FOR THE SUREFORM 45 STAPLER (PN: 480545-4, BATCH-SEQ: L90211004-0094) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE WAS LAST USED ON 16-FEBRUARY-2022 ON SYSTEM SK1127. SUREFORM STAPLERS ARE SINGLE USE INSTRUMENTS. A REVIEW OF THE STAPLER LOGS ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) FAILURE ANALYSIS ENGINEER (FAE). LOGS SHOW THAT THERE WERE QTY 2 SUREFORM 45 INSTRUMENTS USED IN THE PROCEDURE. FIRST INSTRUMENT USED WAS PN 480545-04, LOT T90200923-0081, AND THIS INSTRUMENT WAS INSTALLED 2X AND FIRED 2 RELOADS (BOTH WHITE). FIRST FIRING WAS COMPLETED PER THE LOGS WITH NO PAUSES FOR COMPRESSION. THE SECOND FIRING FAILED AT 68% COMPLETION FOLLOWING 1 PAUSE FOR COMPRESSION. THERE WERE NO INCOMPLETE CLAMPS BY THIS INSTRUMENT. SECOND INSTRUMENT USED WAS PN 480545-04, LOT L90211004-0094, AND THIS INSTRUMENT WAS INSTALLED 2X AND FIRED 2 RELOADS (BOTH WHITE). BOTH FIRINGS WERE COMPLETED PER THE LOGS WITH NO PAUSES FOR COMPRESSION. THERE WERE NO INCOMPLETE CLAMPS BY THIS INSTRUMENT. LOGS ARE ATTACHED. NO IMAGES OR VIDEO WAS SUBMITTED FOR REVIEW. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS REPORTED THE STAPLE LINES WERE NOT IN PROPERLY AND DID NOT TRANSACT THE TISSUE. MISSING OR MALFORMED STAPLES MAY CONTRIBUTE TO AN INCOMPLETE STAPLE LINE. IF NOT RECOGNIZED DURING THE PROCEDURE, MEDICAL INTERVENTION, INCLUDING ADDITIONAL SURGICAL PROCEDURES, MAY BE REQUIRED IF THE STAPLES ARE NOT DELIVERED FROM THE RELOAD. FOLLOW-UP WAS ATTEMPTED, BUT THE MISSING PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE IS NOT APPLICABLE. THE PRODUCT IS NOT IMPLANTABLE. IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA. INSUFFICIENT PRODUCT INFORMATION WAS PROVIDED IN ORDER TO OBTAIN THE DATE OF MANUFACTURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED THORACIC SURGICAL PROCEDURE, AFTER FIRING THE SUREFORM 45 STAPLER, THE STAPLE LINE DID NOT FORM PROPERLY AND THE STAPLER DID NOT TRANSECT THE TISSUE. THE PROCEDURE WAS COMPLETED WITH NO REPORTS OF PATIENT INJURY. INTUITIVE SURGICAL INC (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PART NUMBER AND LOT NUMBER OF THE SUREFORM 45 INSTRUMENT AND RELOAD ACCESSORY WERE UNKNOWN. THE SITE HAS ALREADY DISCARDED THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2366976 SUREFORM SUREFORM 45 RELOAD WHITE GDW INTUITIVE SURGICAL, INC 48345W N/A

    Patients

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