BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFORM

    MDR report key: 15651559 · Received October 21, 2022

    Report

    Report Number
    2955842-2022-14743
    Event Type
    Injury
    Date Received
    October 21, 2022
    Date of Event
    September 21, 2022
    Report Date
    September 21, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K173721
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPLACED THE SUREFORM 60 STAPLER TO RESOLVE THE ISSUE. THE SYSTEM WAS WORKING PROPERLY, AND NO ADDITIONAL ACTION WAS REQUIRED. INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE STAPLER FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. A REVIEW OF THE INSTRUMENT LOG FOR PART NUMBER: 480460-09 BATCH/LOT NUMBER: L13220808-0476 ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE INSTRUMENT WAS LAST USED ON (B)(6) 2022 ON SYSTEM (B)(4) WITH 7 LIVES REMAINING. A REVIEW OF THE ADVANCED LOGS FOR THE SUREFORM 60 STAPLER ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED: THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: LOGS SHOW PN 480460-09, LOT L13220808-0476 WAS INSTALLED 6X AND FIRED 5 RELOADS (ALL BLUE). ALL FIRINGS WERE COMPLETED PER THE LOGS WITH NO PAUSES FOR COMPRESSION. THERE WERE NO INCOMPLETE CLAMPS OR UNCLAMP FAILURES PER THE LOGS. NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. BASED ON THE INFORMATION AVAILABLE AT THIS TIME, THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE STAPLE LINE WAS INCOMPLETE. REVIEW OF STAPLER LOGS CONFIRMED ALL FIRINGS WERE COMPLETED WITH NO INCOMPLETE CLAMPS OR PAUSES FOR COMPRESSION. MISSING 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 DELIVERED FROM THE RELOAD. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RIGHT HEMICOLECTOMY SURGICAL PROCEDURE THAT WHEN THE SUREFORM 60 STAPLER WAS FIRED FOR THE 5TH TIME, THE STAPLES WERE NOT CLOSING NOR SEALING. PRIOR TO CALLING IN, THE CUSTOMER HAD ALREADY SWAPPED TO A NEW SUREFORM STAPLER. THE CUSTOMER CONTINUED WITH THE CASE. THERE WERE NO REPORTS OF PATIENT 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2557985 SUREFORM STAPLER 60 NAY INTUITIVE SURGICAL, INC 480460-09 L13220808 0476

    Patients

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