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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI PERMANENT CAUTERY HOOK Back to Search Results
Model Number 420183-15
Device Problem Thermal Decomposition of Device (1071)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/01/2022
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the permanent cautery hook instrument involved with this complaint and completed the device evaluation. Failure analysis investigations confirmed the customer reported complaint. The instrument was found to have thermal damage on the monopolar yaw pulley and distal clevis. Black char marks were present at the distal end. Any material missing from the damage of the yaw pulley is likely thermally induced rather than mechanically induced. Failure analysis found the primary failure of thermal damage to the yaw pulley and distal clevis to be related to the customer reported complaint. The root cause is not established, but noted to likely be related to mishandling/misuse. There was an additional observation that was related to the reported issue. The instrument was found to have thermal damage on the proximal clevis. Black char marks were present at the distal end. Any material missing from the damage of the proximal clevis is likely thermally induced rather than mechanically induced. The root cause is not established, but noted to likely be related to mishandling/misuse. Failure analysis found the additional failure of thermal damage to the proximal clevis to be related to the customer reported complaint. One side of the distal clevis ear was removed, and the silicone potting did not appear to be compromised. The conductor wire was not damaged around the weld location. The electrical continuity test was performed and passed. No insulation damage was observed on the conductor wire. Failure analysis investigations also found an additional failure not related to the customer reported complaint. Signs of corrosion/contamination were found on the instrument bearings upon housing removal. The input disk bearings exhibited brownish-orange discoloration. As a result, motion at the wrist was not intuitive. Improper cleaning during reprocessing most commonly causes this failure. A review of the logs showed the permanent cautery hook instrument (part# 420183-15 / lot# n10200803-150) was last used on (b)(6)2022 during this reported procedure with system (b)(4). The permanent cautery hook instrument has 10 allotted uses and had 1 use remaining. In addition, a review of the site's complaint history identified no other complaints related to the permanent cautery hook instrument. A review of the provided image was performed by an isi failure analysis engineer (fae). In the image, it looks like there is thermal damage on the yaw pulley, proximal to the ceramic sleeve. This complaint is being reported based on the following conclusion: the permanent cautery hook instrument had incurred damage to the monopolar yaw pulley and was found to have thermal damage on the monopolar yaw pulley and distal/proximal clevis. The initial reported complaint and subsequent failure analysis findings are evidence of electrical discharge at a location other than intended. At this time, it is unknown how the device incurred the observed thermal damage. While there was no patient injury reported, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.
 
Event Description
It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, the customer discovered the "insulation" on the permanent cautery hook instrument was cracked. There was no report of any fragments falling inside the patient. The customer replaced the permanent cautery hook instrument with a back-up instrument of the same kind and completed the procedure with no reported injury. On (b)(6) 2022, intuitive surgical, inc. (isi) performed follow-up and obtained the following additional information regarding the reported event: the instrument was reportedly inspected prior to use, and no issues were noted. The issue occurred during instrument removal. No instrument collision was observed. It was confirmed that no fragments fell inside the patient during the procedure. A video recording of the procedure is not available, but an image of the instrument damage was provided.
 
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Brand NameENDOWRIST;DAVINCI SI
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
izabel nielson
3410 central expressway
santa clara, CA 
4085232100
MDR Report Key14125187
MDR Text Key289419534
Report Number2955842-2022-11080
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K050369
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 03/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number420183-15
Device Catalogue Number420183
Device Lot NumberN10200803 150
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/04/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/16/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/30/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 04/15/2022 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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