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

Model Number 380614-11

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

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

The cause of the reported post-operative complication cannot be determined. After multiple follow-up attempts, no further details have been received as of the date of this report. Regarding the post-operative complication. A follow-up mdr will be submitted if any additional information is received. No image or procedure video was provided. A system log review could not be performed since there is insufficient or unconfirmed product/event information. A review of the site's complaint history does not reveal any additional complaints involving this event. This complaint is being reported due to the following conclusion: it was reported that after a robot-assisted laparoscopic surgery was performed on a woman with early-stage endometrial malignancy, the patient experienced muscle weakness of the lower limbs and sensory disturbance was noted. The patient required the use of crutches and was placed under monitoring after the surgery. Although there is no allegation by the site or the surgeon that an isi device caused or contributed to the reported event or that an isi device malfunctioned, the cause of the post operative complication is unknown.

Event Description

This is a report from a literature review, the median age of the patients was 52 years (44¿57). The efficacy of these surgeries at the beginning of the trial was reviewed retrospectively. The target endometrial cancer cases were grade 1 endometrioid adenocarcinoma, with no muscle invasion visible under imaging. The excised uteruses were submitted to the hospital, and patients with grade 2 or higher lesions or myometrial invasion underwent pelvic lymphadenectomy as an additional procedure. It was reported that a robot-assisted laparoscopic surgery was performed on a woman with early-stage endometrial malignancy. After the surgery, one patient experienced muscle weakness and sensory disturbance caused by being in the head-down and lithotomy position during the long surgery. As a result, the patient required crutches and was monitored after the surgery. To continue performing this surgery in the head-down position, the incline's angle and the duration of the patient's ability to remain in the head-down position continuously may need to be reviewed. Leg extension should be considered in procedures performed in the lithotomy position in general. Thus, when the patients are in a lithotomy position for an extended period, temporarily relaxing the legs mid-surgery may be considered. However, there is no allegation by the site or the surgeon that an intuitive surgical, inc. (isi) device caused or contributed to the reported event or that an isi device malfunctioned. The cause of the reported post-operative complication is unknown. On 05-mar-2021, the following additional information was obtained from the site: the patient details: (b)(6) woman, weighing (b)(6), with a smoking history of 10 cigarettes/day for 15 years. Medical history: diabetes hepatitis b carrier, postoperative graves' disease diagnosis. Surgery time was 493 minutes. Due to in-hospital regulations, at 284 minutes, the procedure was converted to laparoscopic surgery. During the procedure and the laparoscopic conversion there were no reported issues. No additional surgical procedure was required. Postoperatively, the patient experienced fever, lower limb pain, persistent swelling, muscle weakness, and decreased warm pain sensation were observed. Orthopedic surgery diagnosed the symptoms as lower limb muscle crush and nerve compression. As a result, the patient had to use crutches up until a follow-up.

• Brand Name: DAVINCI SI
• 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: david wang ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 11427430
• MDR Text Key: 248789776
• Report Number: 2955842-2021-10204
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K081137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/05/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 380614-11
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2013
• 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