MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI; PATIENT SIDE CART, 4-ARM

Model Number 380652-31

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 02/08/2022

Event Type  Injury  

Event Description

On 08-feb-2022, intuitive surgical, inc.(isi) became aware of ¿the journal of minimally invasive gynecology" article titled, ¿extraperitoneal para-aortic lymphadenectomy by robot-assisted laparoscopy¿ (gomes da costa, a., borghesi, y., et al., 2017).Within the journal article, operative complications were noted: one patient experienced a thermal lesion of the left genitofemoral nerve that was treated, one patient experienced a thermal lesion of the left mesoureter during lymph node dissection (a ureteral stent was placed to avoid uretic necrosis and fistula without after effect), and one patient experienced a lesion of the inferior vena cava with monopolar scissors that was sutured by robot-assisted laparoscopy.For this patient, hemostatic agents were used to contain the hemorrhage, the estimated blood loss was 600 ml, and no post-operative complications were observed.In addition, two (b)(6) old patients experienced perforation of the peritoneum during the robotic extraperitoneal approach after diagnostic laparoscopy.One of these two patients had a bmi of 42 kg/m².The other patient had a bmi of 31 kg/m².Furthermore, it is noted that three patients experienced lymphoceles.These patients were readmitted for abdominal pain and needed imaging-guided or surgical drainage of the lymphoceles.For two of the patients, computed tomographic¿guided percutaneous needle aspiration was performed for a symptomatic lymphocele, and a drain was left in place and removed 10 days later.Isi has reached out to the author to obtain additional information but has not yet received a response.

Manufacturer Narrative

Based on the current information provided, the root cause of the patients¿ reported operative complications cannot be determined or is unknown.If additional information is received, a follow-up mdr will be submitted.A site history complaint review was unable to be conducted at this time due to lack of specific event/procedure detail.There was no image or video clip supplied for review related to a specific event.System or instrument log reviews could not be performed due to a lack of system, procedure, and instrument detail.Further log review is not possible at this time due to lack of system and instrument detail as well as the event/procedure date.An isi clinical development engineer (cde) conducted a clinical article image review and the following was found: thoracic lymphadenectomy is considered an on-label procedure for a xi system.The ports are placed linearly which is expected for xi port placement.I am unable to determine the distance between the ports from the images alone, but the ports do not look excessively close or far from my perspective.Instrument collisions can occur in any procedure due to misuse or anatomical restrictions.Without knowing the distance between the placed ports, i cannot determine whether the port placement would make collisions occur more frequently.The port placement was within our suggested guidelines for the xi system and any misuse of our products that occurred from the article was not determined.This complaint is being reported due to the following conclusion: within the journal article titled, ¿extraperitoneal para-aortic lymphadenectomy by robot-assisted laparoscopy,¿ it is noted that one patient experienced a thermal lesion of the left genitofemoral nerve that was treated and has not recurred and one patient experienced a thermal lesion of the left mesoureter during lymph node dissection.For the second patient, a ureteral stent was placed for precautionary measures and no further complications were observed.At this time the root cause of the intraoperative complications is unknown.Refer to medwatch report with patient identifier (b)(6) for additional information regarding the patient who sustained a lesion of the inferior vena cava.Refer to medwatch report with patient identifier (b)(6) for additional information regarding the three patient who experienced post-operative lymphoceles.Refer to medwatch report with patient identifier (b)(6) for additional information regarding the (b)(6) patient with a bmi of 42 kg/m² who sustained early severe perforation of the peritoneum.Refer to medwatch report with patient identifier (b)(6) for additional information regarding the (b)(6) patient with a bmi of 31 kg/m² who sustained early severe perforation of the peritoneum.

• Brand Name: DAVINCI XI
• Type of Device: PATIENT SIDE CART, 4-ARM
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 13696155
• MDR Text Key: 291807192
• Report Number: 2955842-2022-10532
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110720
• UDI-Public: (01)00886874110720
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 380652-31
• Device Catalogue Number: 380652
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Female