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

Model Number 380614-07

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

Patient Problems Pain (1994); Hernia (2240)

Event Date 05/24/2016

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, the root cause of the customer reported failure mode cannot be determined or is unknown.If additional information is received, a follow-up mdr will be submitted.Site history review was conducted and found no additional complaints related to this event.No image or video clip for the reported event was submitted for review.System error log review was conducted on (b)(6) 2021 for a procedure on (b)(6) 2016 on system (b)(4) and found logged events recorded for the system core as well as other various messages and faults.It was noted that the end of procedure was recorded as 260 minutes; procedure duration of 4.3 hours.A review of the instrument logs was also performed.All reusable instruments used in the case were used in subsequent procedures and a site review shows no known related complaint filed against the instruments with the available information.An isi advanced failure analyst (afa) conducted system log review and found the following: logs show a procedure duration of 260 mins (4 hrs, 20 mins).The logs show no errors logged in the first four hours of the procedure (from start of following time stamp to the first error recorded).The errors all occurred in the last twenty minutes of the procedure, it appears that the core lost ac power, and subsequently the system was restarted.The procedure finished roughly ten minutes after the restart.While the patient alleged a system issue delay, and system messages and faults were recorded in the logs, the system was available for use and the procedure completed robotically.There is no allegation or evidence of a product failure that would be classified as a reportable malfunction.Although patient positioning is determined by, and the responsibility of, the surgical staff/surgeon, there is no allegation of a da vinci product malfunction by the console surgeon or known to be alleged by any other medical professional, and there is no known allegation of an injury due to da vinci-assisted procedure by the console surgeon or known to be alleged by any other medical professional, at this time, the cause(s) of the patient¿s alleged post-operative complications are unknown.

Event Description

It was initially reported by the patient on (b)(6) 2021 that during a da vinci-assisted surgical procedure on (b)(6) 2016, ¿the robot broke down¿ which caused the patient to be under anesthesia for several hours which resulted in ¿complications, most notably a bulging disk by being inverted due to the robot shutting down¿.An electromyography (emg) was ¿done recently¿ and a magnetic resonance imaging (mri) ¿will be done to see how bad the severity of the bulging disk is¿ and it was believed as ¿stemming from being inverted during the procedure¿.After the procedure, the patient ¿was made aware that there was a technician who came to work on the robot during the procedure which added to the delay¿.The patient was told ¿that the doctor who performed the procedure resigned from the hospital the week after the surgery¿.The patient reported, ¿bulging disk in lower back and hernia in stomach that could have been potentially related to being inverted while attached to the system¿, that the patient believes that ¿the injury was caused by the intuitive product/system¿, that the patient has ¿had several hospital visits due to what injuries that were potentially caused by the system malfunction during the procedure, and that the patient is ¿debilitated¿.On 03-may-2021, intuitive surgical, inc.(isi) obtained the following additional information regarding the reported event: the patient alleged that after a da vinci-assisted hysterectomy procedure on (b)(6) 2016, the patient experienced incisional pain for which she took the prescribed pain medication.There was no report of a post-operative follow-up visit by a physician or additional procedures or hospitalization related to the da vinci-assisted procedure.At approximately a year post-operatively, the patient experienced back pain.The patient alleged that ¿the robot broke down¿ causing her to ¿be under anesthesia longer¿ and resulted in complications of ¿a hernia and lower back pain¿ due to ¿the robot shutting down¿.The patient¿s primary care physician was consulted but was not sure what caused the issue.A doctor in a pain management clinic is allegedly currently performing diagnostic testing.An electromyography (emg) was ¿done recently¿ on an unspecified date and a magnetic resonance imaging (mri) will be done soon.The patient said results are unknown and pending.Additional information was not attainable during 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: 11868458
• MDR Text Key: 262026609
• Report Number: 2955842-2021-10558
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 380614-07
• Device Catalogue Number: 380614
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 77