BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 3388862 · Received October 4, 2013

    Report

    Report Number
    2955842-2013-04042
    Event Type
    Injury
    Date Received
    October 4, 2013
    Date of Event
    August 24, 2011
    Report Date
    October 4, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED THE INCOMPLETE OPERATIVE REPORT AND MEDICAL RECORDS FROM THE ATTORNEY REPRESENTING THE PATIENT WHO UNDERWENT A DA VINCI S RADICAL PROSTATECTOMY WITH BILATERAL NERVE SPARING ON (B)(6) 2011. ACCORDING TO THE OPERATIVE REPORT, TREATMENT OPTIONS WERE DISCUSSED WITH THE PATIENT AND THE PATIENT CHOSE TO UNDERGO A DA VINCI RADICAL PROSTATECTOMY. THE PATIENT'S PROSTATE BIOPSIES SHOWED GLEASON 3 + 3 CANCER INVOLVING BOTH SIDES OF HIS PROSTATE. BASED ON THE OPERATIVE REPORT PROVIDED, THERE WAS NO REPORT THAT A MALFUNCTION OF THE DA VINCI S SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THERE WAS ALSO NO REPORT THAT AN INTRA-OPERATIVE COMPLICATION OCCURRED DURING THE SURGICAL PROCEDURE. BASED ON THE POST-PROCEDURE NOTES, THE PATIENT WAS ASSESSED AT BEING FREE FROM INJURY DUE TO POSITIONING, PREP, AND ELECTRICAL EQUIPMENT. THE PATIENT WAS ALSO NOTED AS BEING FREE FROM FOREIGN BODIES. IN ADDITION, THE POST-PROCEDURE NOTES INDICATE THAT THE PATIENT WAS FREE FROM SIGNS OF INFECTION, AND HIS BODY TEMPERATURE AND NEUROVASCULAR STATUS WERE MAINTAINED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    BASED ON THE LIMITED INFORMATION PROVIDED, INTUITIVE SURGICAL HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-SURGICAL COMPLICATION(S) EXPERIENCED BY THE PATIENT. THE INFORMATION RECEIVED DOES NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. INTUITIVE SURGICAL INC. (ISI) HAS ATTEMPTED 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. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: A PATIENT'S ATTORNEY ALLEGED A PUNCTURED BOWEL INJURY AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION FROM AN ATTORNEY REPRESENTING A PATIENT WHO UNDERWENT A DA VINCI S PROSTATECTOMY PROCEDURE ON A (B)(6) 2011, AND ALLEGED TO HAVE SUSTAINED A PUNCTURED BOWEL. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503879 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS2000 A5.1P7

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention DA VINCI S SURG SYSTEM INSTRUMENTS AND ACCESSORIE