BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 2883607 · Received December 21, 2012

    Report

    Report Number
    2955842-2012-01401
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 27, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE INFORMATION PROVIDED BY THE CLINICAL SALES REPRESENTATIVE, THE GYN SURGEON (HE HAD PERFORMED 4-5 CASES) WAS PERFORMING A LENGTHY DVH. THERE WAS A BOWEL PERFORATION AND TEARS IN THE SEROSA OF THE SIGMOID COLON, WHICH WERE NOT NOTICED UNTIL THE ROBOTIC PORTION WAS COMPLETE AND THE SURGEON WAS READY TO UNDOCK THE DAVINCI ROBOT SYSTEM. THE CSR WAS IN THE OPERATING ROOM FOR MOST OF THE CASE AND DID NOT SEE A SPECIFIC CAUSE FOR THE INJURY. THE SURGEON WAS USING A PROGRASP FORCEPS INSTRUMENT TO PUSH/SWEEP THE BOWEL BACK WITH THE SHAFT/WRIST, BUT DID NOT GRAB BOWEL. THE ASSISTANT WAS BLINDLY INSERTING A LAP SUCTION/IRRIGATOR THROUGHOUT THE CASE. ONCE THE SURGEON NOTICED SOME UNUSUAL FLUID IN THE ABDOMEN AT THE END OF THE CASE, SHE CALLED A COLORECTAL SURGEON WHO REPAIRED THE BOWEL LAPAROSCOPICALLY. THE PATIENT RECOVERED WELL AND HAD NO FURTHER COMPLICATIONS. A REVIEW OF THE SYSTEM LOGS SHOWED NO SYSTEM MALFUNCTION OCCURRED DURING THE PROCEDURE PERFORMED ON (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DAVINCI SI HYSTERECTOMY PROCEDURE, WHILE THE SURGICAL STAFF WAS UNDOCKING THE SYSTEM FROM THE PATIENT, IT WAS NOTED THAT THE PATIENT SUFFERED A BOWEL TEAR DURING THE PROCEDURE. ACCORDING TO THE INFORMATION PROVIDED BY INITIAL REPORTED CLINICAL SALES REPRESENTATIVE, THE TIPS OF THE PROGRASP FORCEPS INSTRUMENT WERE NOT USED TO GRAB THE BOWEL, BUT THE SHAFT OF THE INSTRUMENT WAS USED TO RETRACT THE BOWEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A60P7

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES