BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAPLER 45 RELOAD, BLUE

    MDR report key: 6901215 · Received September 28, 2017

    Report

    Report Number
    2955842-2017-00636
    Event Type
    Injury
    Date Received
    September 28, 2017
    Date of Event
    September 1, 2017
    Report Date
    September 5, 2017
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K140553
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE STAPLER 45 INSTRUMENT AND STAPLER 45 RELOADS INVOLVED WITH THE REPORTED EVENT HAVE NOT BEEN RETURNED FOR EVALUATION. NO SUBSEQUENT COMPLAINTS HAVE BEEN REPORTED TO ISI REGARDING THE STAPLER 45 INSTRUMENT INVOLVED WITH THE REPORTED EVENT. THE ROOT CAUSE OF THE PATIENT'S POST-OPERATIVE COMPLICATION IS UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2017. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THE SYSTEM LOGS REVEAL THE 3 BLUE STAPLER 45 RELOADS WERE FIRED AND COMPLETED. NO INCOMPLETE CLAMPS WERE FOUND. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER UNDERGOING A DA VINCI-ASSISTED RIGHT HEMI-COLECTOMY PROCEDURE, THE PATIENT UNDERWENT AN OPEN SURGICAL PROCEDURE TO REPAIR A STAPLE LINE LEAK THAT WAS FOUND POST-OPERATIVELY. HOWEVER, AT THIS TIME, THE ROOT CAUSE OF THE STAPLE LINE LEAK IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER UNDERGOING A DA VINCI-ASSISTED RIGHT HEMI-COLECTOMY PROCEDURE, A STAPLE LINE LEAK WAS IDENTIFIED AND THE PATIENT REQUIRED REOPERATION. ON 09/05/2017, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI SPECIALTY SALES MANAGER, SSM, WHO WAS PRESENT DURING THE SURGICAL PROCEDURE, AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE SURGEON FIRED 3 BLUE STAPLER 45 RELOADS WITH NO ISSUES WHILE USING A STAPLER 45 INSTRUMENT. THERE WERE NO REPORTED CLAMPING, FIRINGS, OR UNCLAMPING ISSUES. THE PATIENT DID NOT EXPERIENCE ANY INTRA-OPERATIVE COMPLICATIONS AND THE DA VINCI-ASSISTED SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. ON AN UNSPECIFIED DATE POST-OPERATIVELY, THE PATIENT WAS FOUND TO HAVE A PIN-SIZED HOLE ON THE STAPLE LINE WHERE THE STAPLER 45 INSTRUMENT WAS USED. THE PATIENT UNDERWENT AN OPEN SURGICAL PROCEDURE ON AN UNSPECIFIED DATE TO REPAIR THE STAPLE LINE LEAK. NO SUBSEQUENT POST-OPERATIVE COMPLICATIONS HAVE BEEN REPORTED. THE SSM SPOKE TO THE SURGEON REGARDING THE REPORTED EVENT; HOWEVER, THE CAUSE OF THE REPORTED POST-OPERATIVE COMPLICATIONS IS UNKNOWN. THERE WAS NO ALLEGATION FROM THE SURGEON THAT THE STAPLER 45 INSTRUMENT OR STAPLER 45 RELOADS MALFUNCTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681550 STAPLER 45 RELOAD, BLUE ENDOSCOPIC INSTRUMENT ACCESSORY NAY INTUITIVE SURGICAL,INC. 48645B M10160405

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention