BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFORM

    MDR report key: 15036683 · Received July 17, 2022

    Report

    Report Number
    2955842-2022-13016
    Event Type
    Injury
    Date Received
    July 17, 2022
    Date of Event
    June 17, 2022
    Report Date
    June 17, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GDW
    UDI-DI
    10886874113827
    PMA / PMN Number
    K173721
    Removal / Correction Number
    ISIFA2022-02-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUREFORM 60 STAPLER AND WHITE RELOAD HAVE BEEN DISCARDED AND ARE NOT AVAILABLE FOR INVESTIGATION PURPOSES. ROOT CAUSE OF THE REPORTED FAILURE MODE COULD NOT BE DETERMINED FOR THIS ALLEGED ISSUE NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. A REVIEW OF THE LOGS FOR THE SUREFORM 60 STAPLER ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) ADVANCE FAILURE ANALYSIS ENGINEER. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: LOGS SHOW THAT THE SUREFORM 60 STAPLER (PART# 480460-09, LOT# L93220104-0291) WAS INSTALLED 7 TIMES AND FIRED 7 RELOADS (5 BLUE FOLLOWED BY 2 WHITE). ALL FIRINGS WERE COMPLETED PER THE LOGS. THE 7TH FIRING (WHITE) HAD 1 PAUSE FOR COMPRESSION, AND THE PREVIOUS 6 FIRINGS HAD NO PAUSES. THERE WERE NO INCOMPLETE CLAMPS BY THIS INSTRUMENT. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT STAPLES WERE MISSING FROM THE STAPLE LINE WITH UNKNOWN CAUSE. THE SURGEON HAD TO SUTURE THE TISSUE TO RESOLVE THE ISSUE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTRIC BYPASS SURGICAL PROCEDURE, A WHITE SUREFORM 60 RELOAD FAILED TO DELIVER STAPLES. THE REPORTER (INTUITIVE SURGICAL, INC. CLINICAL SALES ASSOCIATE/ CSA) WAS PRESENT WHEN THE ISSUE OCCURRED. THE SURGEON USED A SUREFORM 60 STAPLER WITH BLUE AND WHITE RELOADS. ON THE LAST WHITE RELOAD FIRE, THE SURGEON AND REPORTER NOTICED THAT THE JEJUNUM WAS NOT STAPLED CORRECTLY ON ONE SIDE OF THE STAPLE LINE FURTHERMORE, THE REPORTER INDICATED SOME STAPLES WERE MISSING FROM THE RELOAD. THE SURGEON USED A BARBED SUTURE TO CLOSE THE AREA. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. THE REPORTER FOLLOWED UP WITH THE SURGEON SEVERAL DAYS LATER AND WAS INFORMED THAT THE PATIENT WAS DISCHARGED HOME AS PLANNED ON POD 3 AND THERE WAS NO CONSEQUENCES FROM THIS EVENT. THE SUREFORM 60 STAPLER AND WHITE RELOAD WILL NOT BE RETURNED TO INTUITIVE FOR INVESTIGATION AS THEY HAVE BEEN SINCE DISCARDED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT AND ACCESSORIES WERE NOT INSPECTED PRIOR TO USE. THE SURGICAL TASK THAT WAS BEING PERFORMED AT THE TIME OF THE ISSUE WAS THE TRANSECTION OF THE SMALL INTESTINE AND THE WHITE RELOAD WAS SELECTED BECAUSE, IT WAS ADAPTED TO THE TISSUE. THE TARGET TISSUE WAS NOT CALCIFIED AND NOT EXPOSED TO ANY RADIATION OR CHEMOTHERAPY PRIOR TO THE PROCEDURE. THERE WAS NO TISSUE TENSION OR TISSUE BUNCHING OBSERVED. WHEN THE STAPLING ISSUE OCCURRED, NO SYSTEM ERRORS WERE GENERATED AND THE SUREFORM 60 STAPLER FIRED WITHOUT PROBLEM 7 TIMES BEFORE THE ISSUE OCCURRED. THE SURGEON DID NOT ENCOUNTER ANY OBSTRUCTIONS, AND THERE WAS NO CLAMPING ISSUES PRIOR TO FIRING THE STAPLER RELOAD. CSA INDICATED THERE WERE NO MALFORMED STAPLES OBSERVED. THERE ARE NO PHOTOGRAPHIC IMAGES OF THE DEVICE(S) OR A VIDEO RECORDING OF THE PROCEDURE AVAILABLE FOR ISI REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1057584 SUREFORM STAPLER 60 RELOAD WHITE GDW INTUITIVE SURGICAL, INC 48360W-08 T91211012 10886874113827

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES