MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST PERMANENT CAUTERY HOOK

Model Number 470183-14

Device Problems Thermal Decomposition of Device (1071); Smoking (1585)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/17/2021

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc. (isi) received the permanent cautery hook (pch) instrument involved with this complaint and completed the device evaluation. Failure analysis confirmed the reported complaint. The instrument was found to have a broken conductor wire at the weld joint of the yaw pulley after one side of the clevis ear was removed for further investigation. The silicone potting appeared to be compromised and the conductor wire was thermally damaged around the weld location. Any material missing is likely to be thermally induced rather than mechanically induced. The root cause is attributed to the device design. Additionally, it was observed that the pch instrument had thermal damage at the monopolar yaw pulley. It was noted that black char marks were observed. Any material missing is likely to be thermally induced rather than mechanically induced. It was noted the instrument had 8 lives remaining. The root cause is attributed to device design. A review of the site's complaint history does not reveal any additional complaints involving this product and/or this event. No procedure image or video was provided. An instrument log review was conducted, which resulted in the following findings: the logs show the customer last used the pch instrument part# 470183-14 lot# n10210322-0074 on (b)(6) 2021 with system sk0795. The instrument had 8 lives remaining. This last usage of the device per the log review matches the reported event date, indicating that the instrument was not used after the date of the reported event. A review of the site's system logs for the reported procedure date was conducted. Investigation revealed there were no related system errors to have occurred during the surgical procedure that would have likely caused or contributed to the reported complaint. Based on the information provided, this event is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, it was alleged that the permanent cautery hook instrument was smoking. While there was no report of any patient harm, adverse outcome or injury, recurrence of the reported failure mode could cause or contribute to an adverse event. Follow-up was attempted, but the missing patient information was either unknown, unavailable, not provided, or not applicable. Device expiration date was left blank as this instrument has 10 usages allotted to it, which are tracked by the da vinci surgical system. This reported issue occurred on the instrument's 2nd usage and, therefore, had not expired. Implant date (2020 reports) is blank because the product is not implantable. Initial reporter is blank because it is unknown if the initial reporter submitted a report to the fda. Fields pma/510k (2020 reports) , adverse event, recall (if recall number is given) (2020 reports), and correction/removal number (2020 reports) are not applicable.

Event Description

It was reported that during a da vinci-assisted radical extraperitoneal with lymphadenectomy prostatectomy surgical procedure, the customer observed the permanent cautery hook (pch) instrument was smoking from the cable housing area. The procedure was completed with no reported injury. Intuitive surgical, inc. (isi) followed up with the robotic coordinator and obtained the following additional information: the robotic coordinator was not present during the case; however, was informed by the staff that the smoking was observed on the camera. It was stated that the instrument was not burning or touching tissue. The robotic coordinator was unable to answer the remainder of the questions but will attempt to gather the information. No further details have been obtained as of the date of this report. Follow-up: 4 attempts have been made to obtain additional information from the customer concerning the reported event with no success. This complaint will be classified based on the provided information at this time.

• Brand Name: ENDOWRIST
• Type of Device: PERMANENT CAUTERY HOOK
• 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: 11996904
• MDR Text Key: 256141665
• Report Number: 2955842-2021-10653
• 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: health professional,other
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 470183-14
• Device Catalogue Number: 470183
• Device Lot Number: N10210322 0074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2021
• 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 Treatment Data

Date Received: 06/14/2021 Patient Sequence Number: 1

Treatment

DA VINCI INSTRUMENTS AND ACCESSORIES.