BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENACULUM FORCEPS INSTRUMENT

    MDR report key: 4613523 · Received March 18, 2015

    Report

    Report Number
    2955842-2015-00441
    Event Type
    Injury
    Date Received
    March 18, 2015
    Date of Event
    February 16, 2015
    Report Date
    February 16, 2015
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN RELATION TO THE REPORTED EVENT, INTUITIVE SURGICAL, INC. (ISI) RECEIVED VOLUNTARY REPORT (B)(4) ON 06/03/2015 WITH THE FOLLOWING EVENT DESCRIPTION: TENACULUM BENT AND FRACTURED WHILE INSIDE PT'S ABDOMEN. THERE WERE NO FRACTURED PIECES SEEN IN THE ABDOMINAL CAVITY. CAVITY WAS CLEANED OUT DURING THE MIDDLE OF THE PROCEDURE AND AGAIN AT THE END OF THE PROCEDURE. INTUITIVE SURGICAL INC., (B)(4). THIS COMPLAINT WILL REMAIN REPORTABLE DUE TO THE FOLLOWING CONCLUSION: AS NOTED IN THE INITIAL MDR, DURING THE DA VINCI SURGICAL PROCEDURE, THE SHAFT OF THE TENACULUM FORCEPS INSTRUMENT SPLINTERED AND THE SURGEON INCREASED THE SIZE OF ONE OF THE PORT SITE INCISIONS IN ORDER TO RETRIEVE THE FALLEN FRAGMENTS LAPAROSCOPICALLY.

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS NOT BEEN RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. A REVIEW OF THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2015 REVEALED THAT NO SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED IN RELATION TO THE REPORTED INSTRUMENT DAMAGE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING THE DA VINCI SURGICAL PROCEDURE, THE SHAFT OF THE TENACULUM FORCEPS INSTRUMENT SPLINTERED AND THE SURGEON INCREASED THE SIZE OF ONE OF THE PORT SITE INCISIONS IN ORDER TO RETRIEVE THE FALLEN FRAGMENTS LAPAROSCOPICALLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI PROSTATECTOMY PROCEDURE, THE SURGEON NOTICED THROUGH THE ENDOSCOPE THAT THE SHAFT OF THE TENACULUM FORCEPS INSTRUMENT WAS SPLINTERING. AT THE TIME THE EVENT OCCURRED, THE SURGEON WAS ATTEMPTING TO GRASP A PORTION OF THE PATIENT'S PROSTATE. ON (B)(4) 2015, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE SURGEON BELIEVED THAT THE INSTRUMENT BROKE AS A RESULT OF WEAKNESS IN THE SHAFT. BEFORE THE EVENT OCCURRED, THE SURGEON INDICATED THAT HE HAD BEEN USING THE TENACULUM FORCEPS INSTRUMENT FOR ABOUT AN HOUR AND THERE WAS ONLY MINOR CONTACT WITH OTHER INSTRUMENTS DURING THE PROCEDURE. ACCORDING TO THE SURGEON, THE PATIENT WAS DOING WELL POST-OPERATIVELY. THE FRAGMENTS FROM THE SHAFT OF THE INSTRUMENT WERE RETRIEVED LAPAROSCOPICALLY AFTER THE SURGEON LENGTHENED ONE OF THE PORT SITE INCISIONS. NO POST-OPERATIVE TESTS WERE PERFORMED. IN ADDITION, NO POST-OPERATIVE COMPLICATIONS HAVE BEEN REPORTED. ON (B)(4) 2015, ISI ALSO CONTACTED THE SITE'S ROBOTIC COORDINATOR. THE ROBOTICS COORDINATOR INDICATED THAT HE CAME INTO THE OR AFTER THE TENACULUM FORCEPS INSTRUMENT BROKE AND WHILE THE SURGICAL STAFF WAS RETRIEVING THE INSTRUMENT FRAGMENTS. ACCORDING TO THE ROBOTICS COORDINATOR, THE INSTRUMENT WAS INSPECTED PRIOR TO THE START OF THE SURGICAL PROCEDURE AND NO ISSUES WERE FOUND. THE SURGICAL STAFF DID NOT HAVE ANY DIFFICULTY INSERTING THE INSTRUMENT INTO THE CANNULA. HOWEVER, THE SURGICAL STAFF HAD DIFFICULTY ADVANCING THE INSTRUMENT DURING THE PROCEDURE. AT THE TIME THE EVENT OCCURRED, THE SURGEON WAS ATTEMPTING TO RETRACT THE PATIENT'S PROSTATE WITH THE TENACULUM FORCEPS INSTRUMENT WHICH WAS INSTALLED IN PATIENT SIDE MANIPULATOR 3 (PSM3). THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART (PSC) THAT PROVIDES STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184297 TENACULUM FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420207-06 M10110204 535

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention