BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUREFORM

    MDR report key: 17466916 · Received August 4, 2023

    Report

    Report Number
    2955842-2023-17538
    Event Type
    Malfunction
    Date Received
    August 4, 2023
    Date of Event
    July 17, 2023
    Report Date
    July 17, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GDW
    UDI-DI
    10886874113834
    PMA / PMN Number
    K173721
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE BLUE SUREFORM 60 RELOAD WAS ANALYZED AND THE COMPLAINT REGARDING MISSING STAPLES IN THE RELOAD WAS CONFIRMED BY FAILURE ANALYSIS. UPON VISUAL INSPECTION, THE RELOAD WAS FOUND TO BE UNUSED AND NOT FIRED. A MISSING STAPLE WAS OBSERVED. NO DAMAGE TO THE CARTRIDGE OR THE COVER WAS OBSERVED.

    Additional Manufacturer Narrative · 0

    THE RELOAD WAS TRANSFERRED TO THE MANUFACTURING TEAM FOR FURTHER INVESTIGATION INTO THE ASSEMBLY OF LOT K12230223. THERE IS A 100% INSPECTION FOR STAPLE PLACEMENT DURING THE ASSEMBLY OF RELOADS. NO MANUFACTURING ERRORS WERE DETECTED FOR THIS LOT AND THE EVIDENCE DOES NOT SUGGEST A WORKMANSHIP-RELATED FAILURE. AS THE RELOAD WAS ALREADY REMOVED FROM THE PACKAGING, LIKELY, ONE OF THE STAPLES WAS INADVERTENTLY DISLODGED DURING HANDLING PRIOR TO DETECTION BY THE USER. THE STAPLE WAS NOT RETURNED WITH THE RELOAD, HOWEVER, THE RELOAD WAS NOT FIRED AND THE MISSING STAPLE WAS IDENTIFIED PRIOR TO USE.

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIMS AGAINST THE PRODUCT, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. 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.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    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 SURGICAL PROCEDURE, THERE WERE NO STAPLES IN THE SUREFORM 60 BLUE RELOAD. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: AS THE SURGEON WAS MOVING THE STAPLER INSTRUMENT TOWARDS THE STOMACH TISSUE TO FIRE, THE CUSTOMER NOTICED THAT THE LAST FEW ROWS OF STAPLES IN THE RELOAD WERE STICKING OUT. THE CUSTOMER SWAPPED TO A BACKUP AND CONTINUED WITH NO FURTHER ISSUES AND NO HARM TO THE PATIENT. THE DEFECTIVE RELOAD WAS NEVER FIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2320334 SUREFORM STAPLER 60 RELOAD BLUE GDW INTUITIVE SURGICAL, INC 48360B-08 K12230223 10886874113834

    Patients

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