BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 3444471 · Received November 1, 2013

    Report

    Report Number
    2955842-2013-04993
    Event Type
    Injury
    Date Received
    November 1, 2013
    Date of Event
    October 21, 2011
    Report Date
    October 4, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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. THE DOCUMENTATION PROVIDED DID NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST SURGICAL COMPLICATIONS FOLLOWING A DA VINCI SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI SI PROSTATECTOMY PROCEDURE ON (B)(6) 2011 DUE TO PROSTATIC CANCER, STAGE T1C. ISI WAS PROVIDED WITH THE PATIENT'S OPERATIVE REPORT. ADDITIONAL INFORMATION WAS PROVIDED INCLUDED THE PATIENT'S ATTORNEY CLAIM FORM. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE SURGICAL PROCEDURE. THERE WAS NO REPORT OF AN INTRA-OPERATIVE COMPLICATION. REPORTEDLY, THE PATIENT TOLERATED THE SURGICAL PROCEDURE WELL AND WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE AND SATISFACTORY CONDITION. NO OTHER PATIENT MEDICAL RECORDS WERE PROVIDED. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED IN THE PATIENT'S CLAIM FORM: ON (B)(6) 2011, AN EXPLORATORY LAPAROTOMY WITH SMALL BOWEL RESECTION, ABDOMINAL WASHOUT AND WOUND VAC PLACEMENT WAS PERFORMED. OPERATIVE FINDINGS INCLUDE: GROSS ENTERIC SPILLAGE WITH PARTICULATE MATTER, NO PUS, SMALL BOWEL INJURY APPROX 1 CM IN SIZE IN THE MID ILEUM, REMAINING SMALL BOWEL AND LARGE BOWEL APPEARED INTACT, STOMACH WAS NORMAL. ON (B)(6) 2011 - ABDOMINAL WASHOUT WITH ABDOMINAL VAC DRESSING CHANGE. ON (B)(6) 2011 - ABDOMINAL WASHOUT WITH ABDOMINAL VAC DRESSING CHANGE. THE PATIENT WAS DISCHARGED ON (B)(6) 2011. ON (B)(6) 2012 - ADMITTED TO THE ACUTE CARE SURGERY SERVICE WITH CHIEF COMPLAINT OF ABDOMINAL PAIN, NAUSEA AND VOMITING SUGGESTING SMALL BOWEL OBSTRUCTION. DISCHARGE ON (B)(6) 2012. ON (B)(6) 2012 - FOLLOW UP. PATIENT NOW COMPLAINS OF AN INCISIONAL HERNIA. STILL TAKING PAIN MEDICATION AND REPORTS SOME C/O CONSTIPATION. PATIENT DOES HAVE A LARGE INCISIONAL HERNIA. PATIENT STILL WITH SMALL OPEN WOUND WITH INCISION HEALING BY SECONDARY INCISION. LARGE VENTRAL INCISIONAL HERNIA NOTED. PATIENT FOLLOWING WITH SURGERY AND WILL REVIEW OPTIONS OF TREATMENT COURSE. AT THIS TIME AN ELASTIC BINDER MAY BE THE BEST OPTION, HOWEVER, STILL WITH HEALING INCISION RESTRICTING USE OF SUCH A GARMENT DUE TO FRICTIONAL IRRITATION. WILL RECONSIDER THIS OPTION WITH FURTHER HEALING OF ABDOMINAL INCISION. ON (B)(6) 2012 - STILL NOTES INCISIONAL HERNIA STATES THAT PATIENT SUFFERS WITH DEPRESSION RELATED TO THE RESIDUAL DEFICITS STATUS POST-SURGERY. PATIENT DOES REPORT SOME ADDITIONAL LIMITATIONS WITH HIS DAILY ACTIVITIES. ON (B)(6) 2012 - STILL NOTES INCISIONAL HERNIA, STATES THAT PATIENT SUFFERS WITH DEPRESSION RELATED TO THE RESIDUAL DEFICITS STATUS POST-SURGERY. PATIENT DOES REPORT SOME ADDITIONAL LIMITATIONS WITH HIS DAILY ACTIVITIES. PATIENT RESTRICTED FROM HEAVY LIFTING ACTIVITIES. ALSO NOTES HE COMPLAINS OF ABDOMINAL DISCOMFORT AND HE IS TAKING PERCOCET WITH SOME BENEFIT. ON (B)(6) 2012 - PATIENT REPORTS CONTINUED COMPLAINTS OF DISTENTION OF HIS ABDOMEN WITH THE VENTRAL HERNIA. PATIENT USES AN ABDOMINAL BINDER FOR DAILY ACTIVITIES. PATIENT REMAINS WITH A POOR HEALING WOUND OVERLYING THE PREVIOUS INCISION. CONTINUE WITH LOCAL WOUND CARE. CONTINUE TO ENCOURAGE USE OF THE ABDOMINAL BINDER. ON (B)(6) 2012 - PATIENT REPORTS CONTINUED COMPLAINTS OF DISTENTION OF HIS ABDOMEN WITH THE VENTRAL HERNIA. PATIENT USES AN ABDOMINAL BINDER FOR DAILY ACTIVITIES. PATIENT REMAINS WITH A POOR HEALING WOUND OVERLYING THE PREVIOUS INCISION. CONTINUE WITH LOCAL WOUND CARE. CONTINUE TO ENCOURAGE USE OF THE ABDOMINAL BINDER. ON (B)(6) 2012 - HOSPITALIZATION FOR ABDOMINAL PAIN/VOMITING. SUDDEN ONSET OF NAUSEA AND VOMITING LAST NIGHT AT ABOUT 21:30. STATES HE IS HAVING GENERALIZED ABDOMINAL PAIN THAT COMES AND GOES WHICH IS ALWAYS BETTER AFTER HE VOMITS. STATE WHEN HE IS HAVING PAIN IT IS SHARP AND RATES 10/10. DENIES HAVING ANY LOOSE STOOLS. ATE NORMAL YESTERDAY. ABDOMEN IS SOFT AND ROUND AT THIS TIME. HAS LARGE HERNIA ON RIGHT SIDE, HISTORY OF BOWEL SURGERY AS HE STATE HIS BOWEL WAS INJURED WHEN HE HAD PROSTATE SURGERY LAST YEAR. DILATED LEFT HEMI ABDOMINAL SMALL BOWEL LOOPS SUGGESTING CLOSED LOOP OBSTRUCTION, LIKELY DUE TO ADHESIONS. DIVERTICULOSIS AND LARGE VENTRAL HERNIA. ON CT PARTIAL SMALL BOWEL OBSTRUCTION. ON (B)(6) 2013 - PRESENTS FOR FOLLOW UP FROM ER AFTER BOWEL OBSTRUCTION AS WELL AS FOLLOW UP ON HTN AND AFIB. STATUS POST HOSPITAL STAY AND RECOVERING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562004 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R DAV SI SURG SYS INSTRUMENTS, ACCESSORIES & ESU