BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 4103287 · Received September 19, 2014

    Report

    Report Number
    2955842-2014-05382
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    May 14, 2014
    Report Date
    July 22, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE OF THE POST SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2014. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE PATIENT'S POST-OPERATIVE COMPLICATION. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-OPERATIVE COMPLICATIONS AFTER UNDERGOING A DA VINCI SLEEVE GASTRECTOMY PROCEDURE. HOWEVER, THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. ALSO, AT THIS TIME, THE CAUSE OF THE PATIENT'S POST-OPERATIVE COMPLICATIONS IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE, THE PATIENT EXPERIENCED POST-OPERATIVE COMPLICATIONS. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) RECEIVED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE SURGEON WHO PERFORMED THE DA VINCI SURGICAL PROCEDURE. ACCORDING TO THE SURGEON, THE PATIENT UNDERWENT A DA VINCI SLEEVE GASTRECTOMY PROCEDURE ON (B)(6) 2014. ON (B)(6) 2014, THE PATIENT EXPERIENCED SYMPTOMS OF A POST-SURGICAL LEAK. THE PATIENT HAD A SMALL LEAK NEAR THE GASTROESOPHAGEAL (GE) JUNCTION, PRESUMABLY FROM THE STAPLE LINE. THE SURGEON INDICATED THAT INITIALLY IT WAS BELIEVED THAT THE PATIENT HAD AN INFECTED HEMATOMA. PERCUTANEOUS DRAINS WERE PLACED BY RADIOLOGY TO RESOLVE THE ABDOMINAL FLUID COLLECTIONS. AFTER THE PERCUTANEOUS DRAINS WERE REMOVED, THE ISSUE RECURRED. ON (B)(6) 2014 THE PATIENT UNDERWENT LAPAROSCOPIC EXPLORATION AND DRAIN PLACEMENT; HOWEVER, THE LEAK WAS NOT LOCATED. LATER IN THE PATIENT'S COURSE SHE UNDERWENT A PROCEDURE TO HAVE A STENT PLACED TO COVER THE LEAK FROM INSIDE OF THE STOMACH. ACCORDING TO THE SURGEON, AS OF (B)(6) 2014, THE PATIENT WAS IN THE HOSPITAL AND IN STABLE CONDITION. THE SURGEON INDICATED THAT THE PATIENT HAD BEEN IN AND OUT OF THE HOSPITAL SEVERAL TIMES. THE PATIENT'S FLUID COLLECTION WAS RESOLVING AND THE PATIENT WAS HOSPITALIZED DUE TO PAIN FROM THE STENT. IT WAS EXPECTED THAT THE STENT WOULD BE REMOVED IN 2 TO 4 WEEKS. THE SURGEON INDICATED THAT HE DOES NOT KNOW EXACTLY WHAT CAUSED OR CONTRIBUTED TO THE POST-OPERATIVE LEAK EXPERIENCED BY THE PATIENT; HOWEVER, HE INDICATED THAT HE WAS WARY OF USING THE GREEN RELOAD ON THE LEAK PRONE AREA OF THE UPPER STOMACH SINCE THE GREEN RELOAD HAS TWO ROWS OF STAPLES COMPARED TO THREE ROWS ON THE BLUE RELOAD OR OTHER LAPAROSCOPIC STAPLERS. ACCORDING TO THE SURGEON, THERE WAS NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE SURGICAL PROCEDURE. THERE IS NO VIDEO RECORDING OF THE SURGICAL PROCEDURE. ON (B)(4) 2014, THE ISI CLINICAL SALES REPRESENTATIVE (CSR) SPOKE TO THE SURGEON. ACCORDING TO THE CSR, THE SURGEON INFORMED HIM THAT THE CASE HAS GONE TO THE PEER REVIEW BOARD AT THE HOSPITAL. THE CSR ALSO INDICATED THAT THE SURGEON INFORMED HIM THAT HE (THE SURGEON) TOLD THE PEER REVIEW BOARD THAT HE MADE THE INCORRECT CLINICAL DECISION TO USE GREEN RELOADS DURING THE SURGICAL PROCEDURE. ON (B)(4) 2014, ISI CONTACTED THE CSR AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE CSR COULD NOT RECALL IF THE SURGEON PERFORMED AN ANASTOMOTIC LEAK TEST DURING THE DA VINCI SURGICAL PROCEDURE. THE CSR ALSO INDICATED THAT THE SURGEON DID NOT USE STAPLE LINE BUTTRESS MATERIAL DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582616 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R