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

Model Number 380652-48

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Nerve Damage (1979)

Event Date 05/25/2021

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, the root cause of the customer reported incident cannot be determined or is unknown.If additional information is received, a follow-up mdr will be submitted.There was no report or allegation from the customer of a deficiency of the da vinci system, instrumentation, or accessories associated with the reported incident.Therefore, there are no products expected for return to intuitive surgical, inc.(isi) for failure analysis evaluation.Site history complaint review was conducted and did not show any additional complaints related to this event.No image or video clip for the reported event was submitted for review.A review of the system and instrument logs has been performed.There were no observed events in the system logs that would suggest a product issue, and logged events are in line with normal system functionality.All reusable instruments used in the case were used in subsequent procedures.With the exception of a synchroseal instrument which is a single use instrument.A site review shows no complaint filed against this instrument.Since the instruments were not considered to be defective during the procedure, the synchroseal instrument, which is a single-use instrument, has been disposed.The procedure does not have any real-time events stored, so instrument-specific logs are unavailable.The system logs indicate the synchroseal was used for 1 hour and 32 minutes.There were no applicable errors in the system.This complaint is reported due to the following conclusion: it was reported that during a da vinci-assisted hysterectomy and lymph node dissection in a post-chemo-rad patient, the patient injury was identified intraoperatively after lymph node dissection.It was noticed that the obturator nerve had been inadvertently cut.This nerve injury was not repairable.It was reported that the patient has lost adduction of the right leg and consequently the ability to drive and was undergoing physical therapy.It was confirmed that there was no allegation that a malfunction of a da vinci system, instrument, or accessory occurred or caused/contributed to the nerve injury reported.However, the cause of the intra-operative complication is unknown.

Event Description

It was reported that an injury to the patient occurred during a da vinci-assisted hysterectomy and lymph node dissection in a post-chemo-radiation patient.This injury was identified intraoperatively after lymph node dissection.There were swabs placed over the surgical site while the hysterectomy was completed.After removing the swabs, it was observed that the obturator nerve had been inadvertently cut.This was not repairable.The patient has lost adduction of the right leg and consequently the ability to drive.The patient requires physical therapy with no additional hospitalization.On august 31, 2021, intuitive surgical (isi) contacted the site and obtained additional information from a urology surgeon investigating this incident: the instruments were inspected prior to use, and no damage was observed.No malfunction of an isi instrument occurred during the surgery.The patient experienced a transection of the right obturator nerve.An indocyanine green (icg) sentinel node sampling was being done when the complication occurred.The surgeon does not know what the cause of this transection is.The procedure was completed robotically.However, post-operatively the patient experienced weakness of right leg adduction, and physiotherapy will be needed post-operatively.The patient¿s neurological deficit persists, but the patient is adapting and undergoing physical therapy.Isi had requested additional information regarding this event, such as: what was the initial injury that required the swab to be placed when they identified the nerve injury? what surgical task was being performed when the nerve injury occurred? what instrument was in use when the intra-operative complication occurred? does the patient have a permanent disability? what does the surgeon or site believe was the cause of the intra-operative complication? however, no further details have been received as of the date of this report.

Manufacturer Narrative

Additional information can be found in the following fields: g3, g6, h2, h10.Intuitive surgical, inc.(isi) obtained the following additional information from the isi clinical sales manager who spoke with the consultant urologist from the cases.It was confirmed that the procedure was a malignant hysterectomy, and that the operation was prolonged, although he was not sure how long.The initial injury that required the swab to be placed was obscured vision due to bleeding following previous treatment for lymphoma, causing the anatomy to be difficult to identify.The customer acknowledged that the obturator nerve was accidentally cut.When asked if the injury will result in a permanent disability for the patient, the urologist noted, "the muscles will always be denervated but the patient can learn to move her leg without those muscles over time." the synchroseal was reportedly in use at the time the injury occurred.There was no allegation of a malfunction of the synchroseal, and the customer noted that the synchroseal was used across the obturator nerve "by accident." when asked if the site had determined the cause of the incident, the urologist responded, "conclusion is they still don¿t know how it occurred and [the surgeon] should record cases moving forward to review to check if there is a problem.".

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: DAVINCI XI
• Type of Device: PATIENT SIDE CART, 4-ARM
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• MDR Report Key: 12513712
• MDR Text Key: 272750625
• Report Number: 2955842-2021-11170
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110720
• UDI-Public: (01)00886874110720
• Combination Product (y/n): N
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 380652-48
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES; DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Age: 58 YR
• Patient Weight: 77