MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; TIP COVER ACCESSORY

Model Number 400180

Device Problem Arcing (2583)

Patient Problem Burn(s) (1757)

Event Date 12/23/2021

Event Type  Injury  

Manufacturer Narrative

An isi field service engineer (fse) reviewed the system logs and verified that the customer had completed two subsequent cases on the system which included the use of an mcs instrument.According to the fse, there was no repeat of the customer reported issue and the mcs instrument(s) was working as expected.As of (b)(6) 2022, a review of the site's complaint history does not reveal any related complaints involving this product and/or this event.At this time, the cause of the customer reported failure mode is unknown.A follow-up mdr will be submitted if additional information regarding the reported event is obtained.Isi received a video clip related to the alleged complaint.Isi's clinical development engineering team conducted a review of the video clip.The following information was provided: the video shows the surgeon holding a fibroid with a fenestrated bipolar forceps and cutting it with monopolar cautery using the mcs.While the fibroid is contacting the uterus, thermal energy travels from the fibroid to the uterus and creates white patches on the tissue.The video does not show the uterine manipulator in question.The instructions for use (ifu) provides the following: warning: to avoid inadvertent arcing from the instrument, do not fire the instrument if the tip is not in contact with the intended tissue.This complaint is being reported due to the following conclusion: during a da vinci-assisted myomectomy surgical procedure, while the surgeon was cutting the fibroid with the mcs instrument, it was alleged that energy was delivered unintentionally to the uterus.Although the uterus was reportedly burned, the surgeon indicated that no medical intervention was rendered to the patient as a result of the complication and he had no concern for long-term complications.The cause the alleged transfer of energy from the fibroid to the uterus is unknown.Blank mdr fields: follow-up was attempted, but the patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.The product is not implantable.It is unknown if the initial reporter submitted a report to the fda.Insufficient product information was provided in order to obtain the date of manufacture.

Event Description

It was reported that during a da vinci-assisted myomectomy, the surgeon stated that while he was cutting the fibroid with the monopolar curved scissors (mcs) instrument, energy allegedly traveled to the uterus.The site had switched out to a backup mcs instrument and mcs tip cover accessory prior to contacting an intuitive surgical, inc.(isi) technical service engineer (tse) for support.The tse checked the system logs and noted that the logs did not reflect any system related issues.The reporter indicated that the monopolar settings were 4/4.The tse recommended the staff power cycle the erbe generator and replace the monopolar cord; however, the staff did not want to troubleshoot at the time.The surgeon proceeded with the procedure.Isi contacted the surgeon and obtained the following information: the surgeon stated that while he was cutting the fibroid with the monopolar curved scissors instrument, energy traveled to the serosal layer of the uterus that the fibroid was resting on.He stated that he saw some bubbling and no tissue injury that warranted any repair.After consulting with a few other surgeons, it was determined the energy must have traveled through the metal uterine manipulator device.The surgeon indicated that he usually uses a plastic uterine manipulator, and since the fibroid's size was not significant, he used a metal uterine manipulator.The surgeon confirmed that no arcing or malfunction of any instruments or accessories was observed during the case.The surgeon also confirmed that there was no injury to the patient and was not concerned about any long-term complications.

• Brand Name: ENDOWRIST
• Type of Device: TIP COVER ACCESSORY
• 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: 13315468
• MDR Text Key: 287541908
• Report Number: 2955842-2022-10107
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112263
• 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: 12/23/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 400180
• Device Catalogue Number: 400180
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/23/2021
• Initial Date FDA Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES.
• Patient Sex: Female