BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3291536 · Received August 16, 2013

    Report

    Report Number
    2955842-2013-03064
    Event Type
    Injury
    Date Received
    August 16, 2013
    Date of Event
    June 5, 2013
    Report Date
    July 26, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ISI CONTACTED THE MANAGER OF THE O.R. ON (B)(4) 2013 TO OBTAIN ADDITIONAL CLINICAL INFORMATION ABOUT THE INCIDENT AND SHE REFUSED TO PROVIDE INFORMATION TO ISI. ISI LEFT A MESSAGE FOR THE SURGEON TO CONTACT ISI AND HAS NOT RECEIVED ANY NEW CLINICAL INFORMATION ABOUT THE INCIDENT. ISI HAS REVIEWED THE SYSTEM LOGS FOR THIS SITE WITH A PROCEDURE DATE OF (B)(6) 2013 AND NO SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE REPORTED SURGICAL PROCEDURE. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT SUSTAINED A CUT BOWEL AFTER HAVING A DA VINCI SI PROCEDURE. SHE HAD TO HAVE ANOTHER PROCEDURE TO REPAIR HER CUT BOWEL AND WAS IN THE HOSPITAL FOR 14 DAYS FOR AN INFECTION AND RECOVERY OF HER BOWEL INJURY. HOWEVER, AT THIS TIME IT IS UNKNOWN HOW THE PATIENT OBTAINED THE BOWEL INJURY AND IF THE DA VINCI SI SURGICAL SYSTEM CAUSED OR CONTRIBUTED TO THE PATIENT'S INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A DA VINCI SI HYSTERECTOMY SURGICAL PROCEDURE AND SUSTAINED A BOWEL INJURY. INTUITIVE SURGICAL INC. (ISI) SPOKE TO THE PATIENT ON (B)(4) 2013 AND OBTAINED THE FOLLOWING INFORMATION: ON (B)(6) 2013, THE PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE USING A DA VINCI SI SYSTEM. ON (B)(6) 2013, THE PATIENT DEVELOPED SHARP ABDOMINAL PAINS AND ALSO EXPERIENCED GAS LIKE SYMPTOMS. SHE CONTACTED HER SURGEON AND WAS ADVISED TO TAKE GAS MEDICATION FOR HER SYMPTOMS. ON (B)(6) 2013 AROUND 5:30-6:00PM, HER SYMPTOMS PROGRESSIVELY GOT WORSE, HAD A FEVER OF 102 AND WAS TAKEN TO THE HOSPITAL BY PARAMEDICS. ON (B)(6) 2013, THE PATIENT WENT IN FOR AN X- RAY AND IT WAS DISCOVERED THAT THE PATIENT HAD A CUT BOWEL. THE PATIENT WENT IN FOR SURGERY TO REPAIR HER CUT BOWEL AND IT WAS ALSO DISCOVERED THAT PATIENT HAD AN ABSCESS. THE PATIENT WAS ADMITTED IN THE HOSPITAL FOR 14 DAYS FOR AN INFECTION AND RECOVERY OF THE CUT BOWEL. NO FURTHER INFORMATION WAS PROVIDED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396876 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P7

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES