BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3180781 · Received June 20, 2013

    Report

    Report Number
    2955842-2013-02243
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 1, 2013
    Report Date
    August 16, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED MEDICAL RECORDS REGARDING THE PATIENT WHO UNDERWENT A DA VINCI SI LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY, CYSTOSCOPY, LYSIS OF ADHESIONS, AND PLACEMENT OF ON-Q PAIN PUMP ON (B)(6) 2013. BASED ON THE MEDICAL RECORDS PROVIDED, THE PATIENT'S PRE-OPERATIVE DIAGNOSES WERE MENORRHAGIA, PELVIC PAIN, FIBROIDS, AND AN ENDOMETRIAL MASS. ACCORDING TO THE OPERATIVE REPORT, THE PATIENT WAS THOROUGHLY COUNSELED REGARDING THE RISKS OF SURGERY WHICH INCLUDED BUT WERE NOT LIMITED TO BLEEDING, NERVE INJURY, PROBLEMS OF ANESTHESIA, DEEP VEIN THROMBOSIS, AND INJURY TO SURROUNDING STRUCTURES INCLUDING THE BOWEL, BLADDER, BLOOD VESSELS, AND URETERS. INFORMED CONSENT WAS OBTAINED. ACCORDING TO THE OPERATIVE REPORT, THE SURGEON INDICATED THAT DUE TO THE PATIENT'S BODY HABITUS, MARKED DIFFICULTY WAS ENCOUNTERED THROUGHOUT THE ENTIRE PROCEDURE AND AN EXTRA HOUR AND A HALF OF OPERATIVE TIME WAS NEEDED. THE SURGEON NOTED IN THE OPERATIVE REPORT THAT THE PATIENT HAD EXTREMELY DENSE SCAR TISSUE FROM THE LEFT PELVIC SIDEWALL TO THE LEFT ANTEROLATERAL ASPECT OF THE UTERUS WHICH WAS CAREFULLY DISSECTED USING BLUNT DISSECTION AND MONOPOLAR CAUTERY. AS A RESULT OF DIFFICULTY WITH VISUALIZATION DUE TO THE BOWEL, THE SURGEON MADE THE DECISION TO PROCEED WITH THE REMAINDER OF THE PROCEDURE VAGINALLY. THE ROBOTIC INSTRUMENTS WERE REMOVED AND THE ROBOT WAS UNDOCKED. THE SURGEON STATED IN THE OPERATIVE REPORT THAT THE VCARE UTERINE MANIPULATOR WAS NOTED TO HAVE PERFORATED THE POSTERIOR ASPECT OF THE UTERUS. HOWEVER, THE SURGEON NOTED THAT THERE WAS NO EVIDENCE OF BOWEL OR VASCULAR INJURY. THE SURGEON ALSO NOTED THAT MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE AT ENTERING THE ANTERIOR AND POSTERIOR CUL-DE-SAC. EVENTUALLY, THE SURGEON WAS ABLE TO ENTER THE POSTERIOR CUL-DE-SAC AND THE POSTERIOR CUFF WAS RUN USING 0 VICRYL IN A RUNNING, LOCKED FASHION. THE REMAINDER OF THE UTERO-OVARIAN LIGAMENTS WERE CLAMPED, CUT, AND SUTURE LIGATED UNTIL THE UTERUS WAS FREE. THE SURGEON STATED THAT THIS WAS EXTREMELY DIFFICULT DUE TO THE PATIENT'S BODY HABITUS. TOWARDS THE END OF THE PROCEDURE, THE SURGEON INDICATED THAT A SURVEY OF THE PELVIS REVEALED HEMOSTASIS. AFTER A CYSTOSCOPY WAS PERFORMED AND NO ISSUES WERE FOUND, A SPONGE STICK WAS PLACED IN THE VAGINA AND HEMOSTASIS WAS CONFIRMED. THE SURGICAL PROCEDURE WAS COMPLETED AND NO INTRA-OPERATIVE COMPLICATIONS WERE REPORTED. POST-OPERATIVELY, THE PATIENT DEVELOPED AN ABDOMINAL WOUND INFECTION ALONG WITH AN ENTEROCUTANEOUS FISTULA, ACUTE RENAL FAILURE THAT WAS RESOLVED COMPLETELY, AND A RIGHT LOWER EXTREMITY DVT (DEEP VEIN THROMBOSIS). ON (B)(6) 2013, THE PATIENT UNDERWENT WOUND EXPLORATION AND WAS PLACED ON BROAD-SPECTRUM ANTIBIOTICS PER INFECTIONS DISEASE. SHE WAS ALSO PLACED ON TOTAL PARENTERAL NUTRITION (TPN) AND TRANSFERRED TO REHABILITATION. FROM (B)(6) 2013 THROUGH (B)(6) 2013, MULTIPLE CHEST X-RAYS WERE PERFORMED ON THE PATIENT DUE TO REPORTED COMPLAINTS OF CHEST PAIN AND SHORTNESS OF BREATH. IN ADDITION, MULTIPLE CT SCANS OF THE PATIENT'S ABDOMEN AND PELVIS WERE PERFORMED BETWEEN (B)(6) 2013 AND (B)(6) 2013 DUE TO REPORTED COMPLAINTS OF ABDOMINAL PAIN. THE CT SCAN PERFORMED OF THE PATIENT'S ABDOMEN ON (B)(6) 2013 REVEALED MULTIPLE PELVIC ABSCESSES. THAT SAME DAY, CT GUIDED DRAINAGE OF A LEFT ANTERIOR PELVIC COLLECTION WAS PERFORMED AND A CATHETER WAS LEFT IN THE PELVIC COLLECTION FOR FUTURE DRAINAGE. ON (B)(6) 2013, THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY WITH EXTENSIVE LYSIS OF ADHESIONS AND ILEOCECAL RESECTION. ALSO, DURING THE PROCEDURE, A WOUND VAC WAS PLACED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL TO A REHABILITATION CENTER ON (B)(6) 2013. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER THE DATE OF DISCHARGE FROM THE HOSPITAL ON (B)(6) 2013.

    Additional Manufacturer Narrative · 1

    IN RELATION TO THE COMPLAINT, THE SITE RETURNED TO INTUITIVE SURGICAL INC. (ISI) A MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT THAT WAS USED DURING THE SURGICAL PROCEDURE. THE INSTRUMENT WAS EVALUATED AND FOUND TO BE FULLY FUNCTIONAL WITH NO DAMAGE OR TROUBLE OBSERVED. ON (B)(4) 2013, ISI CONTACTED THE RISK MANAGER AT THE SITE AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. SHE INDICATED THAT THE PATIENT'S INJURY OCCURRED DUE TO THE DIFFICULTY OF THE CASE IN RELATION TO THE PATIENT'S SIZE, GIRTH, AND ANATOMY. SHE WAS UNABLE TO PROVIDE DETAILS AS TO HOW THE PATIENT'S INJURY OCCURRED. TO HER KNOWLEDGE, THERE WAS NO MALFUNCTION OF THE DA VINCI SI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY DURING THE SURGICAL PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY INTRA-OPERATIVE COMPLICATIONS AND WAS DISCHARGED ON AN UNSPECIFIED DATE/TIME. ACCORDING TO THE RISK MANAGER, A COUPLE OF DAYS LATER AFTER THE SURGERY WAS COMPLETED, THE PATIENT EXPERIENCED UNSPECIFIED SYMPTOMS AND RETURNED TO THE HOSPITAL. THE RISK MANAGER INDICATED THAT THE SITE EVALUATED THE PATIENT AND DISCOVERED THAT THE PATIENT HAD SUSTAINED A BOWEL INJURY. THE SITE BELIEVES THE PATIENT'S BOWEL WAS SOMEHOW PERFORATED DURING THE DA VINCI SI HYSTERECTOMY PROCEDURE. SHE WAS UNABLE TO PROVIDE A DESCRIPTION OF THE PERFORATION. ACCORDING TO THE RISK MANAGER, THE BOWEL INJURY DID NOT APPEAR TO BE A THERMAL INJURY. A SECONDARY OPEN SURGICAL PROCEDURE WAS PERFORMED ON AN UNSPECIFIED DATE/TIME TO REPAIR THE PATIENT'S BOWEL INJURY. SINCE THE SECONDARY SURGICAL PROCEDURE WAS PERFORMED, THE PATIENT HAS BEEN IN AND OUT OF THE HOSPITAL. INTUITIVE SURGICAL INC. (ISI) HAS MADE SEVERAL ATTEMPTS TO CONTACT THE SURGEON 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. AT THIS TIME, THERE IS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THE INITIAL REPORTER OF THIS COMPLAINT INDICATED THAT THE SURGEON DID NOT THINK THE PATIENT'S INJURY WAS DUE TO THE MONOPOLAR CURVED SCISSORS INSTRUMENT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE SURGICAL STAFF CLAIMED THAT A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE SUSTAINED A BOWEL INJURY. HOWEVER, IT IS UNKNOWN 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, WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE, SUSTAINED AN UNSPECIFIED BOWEL INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280077 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES