MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI; VISION SIDE SYSTEM

Model Number 381121-40

Device Problem Firing Problem (4011)

Patient Problem Burn(s) (1757)

Event Date 12/08/2021

Event Type  Injury  

Event Description

It was reported that during a da vinci-assisted benign hysterectomy procedure, auto-activation was turned on, causing the monopolar energy to activate unexpectedly.As a result, the patient was allegedly burned.It is unknown what part of the patient was burned and what task the surgeon was performing when the burn injury occurred.The intuitive surgical, inc.(isi) technical support engineer (tse) reviewed the system logs and found error 25913, with the erbe generator generating error m-35.These errors indicate an activation request on a non-mounted instrument.The site reported that they were using an unspecified 3rd party monopolar instrument that was connected to the erbe generator.The 3rd party monopolar instrument was connected to the erbe generator while the maryland bipolar instrument was also connected.The caller was not sure if the 3rd party monopolar instrument was connected to the bipolar port as they were not in the room when the event occurred.The caller also did not have any information on the reported patient burn.The site reported continuing the procedure with a 3rd party electrosurgical unit (esu) rather than continuing with the erbe after this event.The procedure was reportedly continued without all troubleshooting steps completed with the tse.The isi field service engineer (fse) spoke to the robotics coordinator at the site who stated that the issue was not with the erbe generator and that the third party monopolar instrument was replaced after this event occurred to continue the procedure.Isi performed multiple follow-up attempts to obtain additional information from the surgeon of this procedure.However, as of the date of this report, no further details have been received.

Manufacturer Narrative

Based on the information provided, the cause of the reported complication has been determined by the customer to be related to a third party product.The customer initially alleged that the erbe integrated electrical surgical unit (iesu) caused or contributed to this event.However, when the isi fse went on site to inspect the erbe generator, the customer told the fse they believe the issue was with the third party monopolar instrument.Therefore, no product is expected to be returned.A follow-up mdr will be submitted if additional information is obtained.The reported issue was initially addressed with phone support.An isi fse scheduled a site visit to evaluate the erbe generator, but the fse was unable to test the erbe generator at the scheduled time because the erbe generator was being used in a surgical procedure.The customer stated that they believe the issue was with the third party monopolar instrument they were using.The fse scheduled another site visit to test the erbe; however, the customer informed the fse that they believe this issue was caused by the third party monopolar instrument they were using during the procedure.No site visit was conducted.The system was working properly according to the customer site and no additional action was required.An isi failure analysis engineer and an isi clinical development engineer reviewed this reported event and the following information was provided: the third party cautery pen cannot be activated via da vinci (dv) controls or by any da vinci setting.The cautery pen only receives energy from the erbe when commanded to activate via controls on the pen itself, or by external, installed foot pedals.An isi senior manager of technical support reviewed this event and provided the following information: "an error 25913 in combination with an erbe m-35 would indicate the monopolar/bipolar energy cannot be fired from the surgeon console.The surgeon would press an energy activation pedal on the console, no beep would occur, and there would be no energy.M-35 simply would indicate that the dv system requested an activation of a non-mounted dv instrument.When we see these errors, we would suspect an issue with an external pedal connected to the erbe or the customer using a bovie pen in combination with monopolar/bipolar energy activation." this event is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, the patient sustained a burn on an unknown location and to an unknown degree.The burn was allegedly caused by a third party monopolar instrument plugged into the erbe generator for energy.

• Brand Name: DAVINCI XI
• Type of Device: VISION SIDE SYSTEM
• 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: 13195112
• MDR Text Key: 285691570
• Report Number: 2955842-2022-10020
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110898
• UDI-Public: (01)00886874110898
• 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,Health Professional
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 381121-40
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2021
• Initial Date FDA Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2021
• 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