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

Model Number 380652-48

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

Patient Problems Nerve Damage (1979); Pain (1994)

Event Date 03/30/2021

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, the cause of the reported complication cannot be determined. There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred. Therefore, no product is expected to be returned. A follow-up mdr will be submitted if additional information is obtained. No images or videos were obtained for this reported event. A review of the system logs for the procedure date of (b)(6) 2021 has been performed and the following was observed: no relevant errors were observed during this procedure. Additionally, all instruments used in the case were used in subsequent procedures, with the exception of the following: one fenestrated bipolar forceps instrument (serial number: (b)(4)/ 13 uses remaining. ) a site review has shown that both of the endoscopes used during this procedure (serial numbers: (b)(4) and (b)(4)) have complaints created against them and were returned for failure analysis investigations. However, both of these endoscope had complaints created on (b)(6) 2021 and were used in numerous procedures between (b)(6) 2021 and the complaint creation for this event. No other instruments used during this procedure have a complaint made against them at this time. This event is being reported due to the following conclusion: after undergoing a da vinci-assisted nephrectomy procedure, the patient allegedly experienced nerve damage that requires them to walk with a cane. The patient underwent additional treatment and exams as a result of this injury. The cause of the alleged post-operative complication is unknown. There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred. Blank mdr fields: follow-up was attempted, but the missing patient information was either unknown, unavailable, not provided, or not applicable. The expiration date is not applicable. The product is not implantable. Information is not available. It is unknown if the initial reporter submitted a report to the fda. Are not applicable.

Event Description

It was reported by the patient of the procedure that after a da vinci-assisted nephrectomy procedure with removal of a ureter, the patient awoke from surgery with "extreme pain" in their right leg and could not walk. The surgical procedure reportedly lasted 7. 5 hours. The patient reported visiting the emergency room and undergoing neurology exams, nerve conduction tests, mri imaging, a neurosurgeon exam, and physical therapy, and reported having nerve damage. The patient reported that their status is improving but currently requires a cane to walk. Intuitive surgical, inc. (isi) performed multiple follow-up attempts to obtain additional information. However, as of the date of this report, no further details have been received.

• 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: 12874673
• MDR Text Key: 285070139
• Report Number: 2955842-2021-11607
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 380652-48
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2020
• 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 Treatment Data

Date Received: 11/25/2021 Patient Sequence Number: 1

Treatment

DA VINCI INSTRUMENTS AND ACCESSORIES.