BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFORM

    MDR report key: 18141203 · Received November 15, 2023

    Report

    Report Number
    2955842-2023-20089
    Event Type
    Injury
    Date Received
    November 15, 2023
    Date of Event
    October 5, 2023
    Report Date
    October 17, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GDW
    UDI-DI
    10886874113834
    PMA / PMN Number
    K173721
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: ONLY TWO BLUE RELOADS WERE REPORTED BY THE CUSTOMER. THESE TWO BLUE RELOADS WERE REPORTED IN PATIENT IDENTIFIER# 801253 AND 801255.

    Additional Manufacturer Narrative · 0

    AN RMA WAS ISSUED TO EVALUATE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. THE ROOT CAUSE OF THE CUSTOMER-REPORTED FAILURE MODE COULD NOT BE DETERMINED AS THE PRODUCT WOULD NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RIGHT HEMICOLECTOMY SURGICAL PROCEDURE, THE SUREFORM 60 STAPLER STOPPED FIRING. THE STAPLER COULD BE USED NORMALLY BEFORE THE ISSUE OCCURRED. THE SURGEON BELIEVED THAT THE STAPLER STOPPED BECAUSE IT WAS FIRED OVER OVERLAPPING STAPLES. THE SITE WAS COMPLETING THE PROCEDURE AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE STAPLER AND RELOADS WERE INSPECTED PRIOR TO USE WITH NO ABNORMALITY. THE BLADE WAS EXPOSED. THE ISSUE WAS RESOLVED BY REPLACING THE STAPLER. THE ISSUE OCCURRED DURING THE FIRST FIRE WHEN AN OVERLAP RECONSTRUCTION SURGICAL TASK WAS PERFORMED. THE TARGET TISSUE WAS THE COLON TISSUE. THE TISSUE WAS NOT CALCIFIED OR EXPOSED TO ANY RADIATION OR CHEMOTHERAPY. THERE WAS NO TISSUE TENSION OR TISSUE BUNCHING. THE REPORTED ISSUE INVOLVED A PARTIAL FIRE. THERE WAS NO TISSUE PUSH. THE EVENT DID NOT INVOLVE THE STAPLER JAWS OPENING/RELEASING DURING THE FIRING SEQUENCE. THE SURGEON NOTICED THAT THE ISSUE MIGHT OCCURRED DUE TO RESIDUAL STAPLES BEING CAUGHT BETWEEN THE TISSUES. THESE STAPLES FELL INTO THE PATIENT¿S ANATOMY DURING SPECIMEN RESECTION BEFORE THE OVERLAP RECONSTRUCTION. THE STAPLES WERE FORMED PROPERLY IN B-SHAPE. THE FALLEN STAPLES WERE REMOVED BY CLEANING AND SUCTION. NO ADDITIONAL SURGICAL PROCEDURE IS REQUIRED TO REMOVE THE FRAGMENT. THE RELOAD WAS NOT STUCK TO THE TISSUE. THE FOLLOWING MESSAGES APPEARED WHEN THE ISSUE OCCURRED: ¿UNABLE TO COMPLETE FIRE¿, ¿BLADE MAYBE EXPOSED¿, ¿TISSUE TOO THICK TO CONTINUE¿. THERE WAS NO UNPLANNED TISSUE REMOVAL. NO POST-OPERATIVE TEST WAS PERFORMED. THE PATIENT DID NOT RETURN TO THE HOSPITAL DUE TO ANY POST-SURGICAL COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907155 SUREFORM STAPLER 60 RELOAD BLUE GDW INTUITIVE SURGICAL, INC 48360B-08 L10221109 0001 10886874113834

    Patients

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