MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Bleeding (1888); Bowel Perforation (2668); Unspecified Tissue Injury (4559)
Date of Event	04/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No investigation could be performed as the article did not provide any specific information regarding the procedure date or da vinci system identifiers.There was no report of, or indication of, any da vinci product issues.There is no indication that any da vinci products contributed to the reported complications.Citation: markauskas a, blaakær j, traen kj, neumann ga, chunsen w, petersen lk.Morbidity following robot-assisted surgery in a gynecological oncology setting: a cohort study.Acta obstet gynecol scand.2024 aug;103(8):1672-1679.Doi: 10.1111/aogs.14852.Epub 2024 jun 14.Pmid: 38874351; pmcid: pmc11266637.Section a: patient information - no specific patient demographics were provided for this patient.The mean of the patients was 63 years, and patients were all females according to the type of the procedure section b3: due to the lack of specific information regarding the event date associated with the adverse event, an alternate date, published date has been used.Section d - suspect medical device: due to the lack of specific information regarding the da vinci system associated with the adverse event, a generic system material number was used.
Event or Problem Description
Ta literature article was reviewed that described a cohort study of 2225 patients that underwent robot-assisted surgery (ras) in gynecological oncology from january 2015 to december 2022.The aim of the study was to provide a comprehensive description of perioperative morbidity associated with ras in gynecological oncology to enhance preoperative counseling and support shared decision-making.A gynecological oncologist performed the surgery in 98% of the cases, and 64% of these surgeons were already experienced in ras (>50 robotic procedures).The da vinci si system was used in 524 cases and the da vinci xi system in 1701 cases.The study reported 64 intraoperative complications, with bowel injuries being the most common.Two patients experienced trocar lesions of the colon requiring conversion to laparotomy, while the other bowel lesions (typically serosal tears or thermal lesions) were handled by robot-assisted suturing.Vascular complications occurred in 16 patients, including one blunt lesion of the abdominal aorta during entry with a blunt-tip trocar in a very slim patient, and 1 lesion of the right external iliac vein following lymphadenectomy after pelvic irradiation.Both cases required conversion to laparotomy, while robot-assisted suturing was sufficient in the remaining 14 cases.Additional intraoperative issues occurred in 9 patients, 3 had severe subcutaneous emphysema resulting in hypercapnia, 2 had a thermal injury of the obturator nerve, one sustained injury of the thoracic duct, and one had bleeding from a torn rectus abdominis muscle after mini-laparotomy.Four patients had an intraoperative injury of the urinary bladder, all managed during ras.Three patients sustained an intraoperative ureter injury requiring robot-assisted insertion of a jj-stent with suturing in 2 cases and neo-implantation of the ureter by laparotomy in 1 case conversion to laparotomy occurred in 49 cases with severe intra-abdominal adhesions as the most common cause in 24 cases.Unexpected disseminated disease was the second most common cause in 7 cases.Other causes for conversion included an enlarged uterus in 6 cases, poor exposure in 4 cases, trocar injuries of the abdominal aorta or colon in 3 cases, inability to tolerate a steep trendelenburg position in 2 cases, and a ventral hernia in 1 case.The article notes several postoperative complications were reported in 57 cases as major events (grades 3¿5), with 43 patients requiring reoperations.Postoperative bleeding occurred in 40 cases (1.8%), with 12 (0.5%) necessitating surgical intervention.Vaginal vault rupture was noted in 21 cases (0.9%), while herniation of the bowel or omentum occurred in 12 cases (0.5%).Seven of these 12 cases were related to an 8-mm robotic port, three cases were related to a 12-mm camera port, and there was one case with internal intestinal herniation and one case with herniation in a known umbilical hernia.Chylous ascites and wound infections were documented in 10 cases each (0.4%), with 6 wound infections (0.3%) requiring surgery.Nine patients (0.4%) had a diagnosed injury of the urinary tract: one perforation of the urinary bladder and eight ureteric fistulas.Thromboembolic events were rare, occurring in 5 cases (0.2%), with similar rates between groups receiving different prophylaxis regimens.Four patients had a verified symptomatic thromboembolic event (tee) after an intended ras, and all with a malignant diagnosis.Two patients had pulmonary embolism: one after radical hysterectomy and pelvic lymphadenectomy for cervical cancer and one after conversion to laparotomy due to inability to tolerate the trendelenburg position for endometrial cancer.One patient experienced deep venous thrombosis after staging pelvic lymph adenectomy for endometrial cancer.One patient had a stroke after robot-assisted hysterectomy and sentinel lymph node mapping for endometrial cancer.There were no da vinci device malfunctions reported, nor did the authors allege that isi products caused or contributed to any adverse events.The study concluded that ras in a high-volume gynecological oncology setting resulted in low rates of major perioperative morbidity and conversion to laparotomy.The findings support the use of ras for suitable patients and highlight its safety profile when performed by experienced surgeons.The designated author was contacted and confirmed that none of the complications described in the article can be attributed to the da vinci devices alone.Per the author, some complications are unavoidable or even expected as serosal tears of the bowel or small thermal lesions may happen during extensive adhesiolysis or during very complex surgeries in tight spaces.The author confirmed that there were no da vinci device malfunctions that have been associated with any of the complications described in the article.

• Brand Name: DA VINCI
• Common Device Name: DA VINCI
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 20941984
• Report Number: 2955842-2024-23104
• Device Sequence Number: 4619088
• Product Code: NAY
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2024
• Initial Report FDA Received Date: 12/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female