BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 3156969 · Received June 8, 2013

    Report

    Report Number
    2955842-2013-02052
    Event Type
    Other
    Date Received
    June 8, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 10, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2013, THE INTUITIVE SURGICAL INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR), WHO INITIALLY REPORTED THIS COMPLAINT, INDICATED THAT SHE INSPECTED THE INSTRUMENTS THAT WERE USED DURING THE REPORTED PROCEDURE. ACCORDING TO THE CSR, THE INSTRUMENTS APPEARED AS THOUGH THEY HAD NOT BEEN CLEANED PROPERLY. THE CSR SUSPECTED THAT THE REPORTED NON-INTUITIVE MOVEMENT ISSUE MIGHT HAVE BEEN RELATED TO A POSSIBLE ISSUE WITH THE SITE'S INSTRUMENT STERILIZATION PROCESS. IN TURN, THE CSR REPORTEDLY NOTIFIED AN ISI STERILE REPROCESSING SPECIALIST (SRR) OF HER FINDINGS. ISI CONTACTED THE SRR ON (B)(4) 2013, TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE SRR WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION SINCE HE WAS WAITING FOR PERMISSION FROM THE SITE TO COME IN AND PERFORM AN INVESTIGATION OF THEIR INSTRUMENT STERILIZATION PROCESSES. ON (B)(4) 2013, AN ISI FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION OF THE SITE'S DA VINCI S SYSTEM. THE FSE CHECKED THE CABLE TENSION ON ALL 3 PATIENT SIDE MANIPULATOR (PSM) ARMS. THE CABLE TENSIONS WERE REPORTEDLY FOUND TO BE WITHIN SPECIFICATION. THE SYSTEM WAS TEST DRIVEN BY THE FSE AND A SINE CYCLE WAS PERFORMED. ACCORDING TO THE FSE, THE SYSTEM PERFORMED NORMALLY AND WAS FOUND TO BE WITHIN SPECIFICATION. PROPER OPERATION OF THE SYSTEM WAS VERIFIED BY THE FSE. INTUITIVE SURGICAL HAS MADE SEVERAL ATTEMPTS TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE SURGICAL STAFF INDICATED THAT A DA VINCI S TORS PROCEDURE WAS CONVERTED TO OPEN SURGICAL TECHNIQUES AFTER A NON-INTUITIVE MOVEMENT ISSUE OCCURRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S TRANSORAL ROBOTIC SURGERY (TORS) PROCEDURE, A NON-INTUITIVE MOVEMENT ISSUE OCCURRED. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, THE SURGICAL PROCEDURE WAS REPORTEDLY CONVERTED TO OPEN SURGICAL TECHNIQUES. NO PATIENT INJURY WAS REPORTED. NO FURTHER CLINICAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255425 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS2000 A5.1P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DA VINCI SI SURG SYS INST., ACCESSORIES, & ESU