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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC ENDOWRIST PERMANENT CAUTERY HOOK Back to Search Results
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.
 
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Brand NameENDOWRIST
Type of DevicePERMANENT 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 Key11996904
MDR Text Key256141665
Report Number2955842-2021-10653
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131861
Number of Events Reported1
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 Received06/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number470183-14
Device Catalogue Number470183
Device Lot NumberN10210322 0074
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/28/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/18/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/18/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 06/14/2021 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES.
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