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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 02/21/2022
Event Type  malfunction  
Event Description
It was reported that during a da vinci-assisted cholecystectomy surgical procedure, the robotics coordinator (roco) called an intuitive surgical, inc. (isi) technical support engineer (tse) to report that the surgeon stated there was smoke coming from the wires near the base of the tip of the permanent cautery hook instrument. The surgeon noticed this while they were removing the gallbladder and only had a short amount left to remove. They noticed it because they were getting a good amount of smoke. Roco stated that the customer did not note anything frayed or broken on the instrument. The instrument worked fine and since the issue was not noticed until the gallbladder was almost out, so the instrument was not removed. Roco stated that the customer was able to complete the procedure with the same instrument and did not have any additional issues during the procedure. Tse viewed live logs and found no relevant errors. Tse recommended returning the instrument for failure analysis. The procedure was completed with no reported injury. Isi followed up with the initial reporter and obtained the following additional information: the instrument was inspected. There was no visual damage to the instrument. The surgical task involved was cauterizing and dissecting. Monopolar coagulation energy was used. The monopolar cord was not connected to the bipolar instrument. The erbe generator was used. The settings were 4 for cut and 4 for coagulation. There was no instrument collision. There was no arcing involved. The instrument was making a smoke plume near the cables when the energy was activated. The surgeon noted it was smoking a lot, not at the tip but at the cables. It worked fine and was not noticed until almost to the end of the procedure. This event occurred on the first use of the instrument. The procedure was completed with no injury to the patient.
 
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the permanent cautery hook instrument associated with this complaint and completed its investigation. The failure analysis investigations replicated/confirmed the customer reported complaint. Failure analysis found the primary finding of yaw pulley thermal damage to be related to the customer reported complaint. One of the distal clevis ears were cut off to inspect the conductor wire. The conductor wire was found to be damaged at the weld causing the thermal damage on the yaw pulley and conductor wire cap. The electrical continuity test failed. The root cause of this failure is a device design failure. A review of the site's complaint history does not show any additional complaints related to this product and/or this event. No image or video clip for the reported event was submitted for review. 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. Per system logs the permanent cautery hook instrument associated with this event was last used on (b)(6) 2022 on system (b)(4). The instrument had 7 uses remaining. This complaint is being classified as a reportable event due to the following conclusion: there was evidence of thermal damage to the weld. While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.
 
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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
izabel nielson
3410 central expressway
santa clara, CA 
4085232100
MDR Report Key13865356
MDR Text Key287771245
Report Number2955842-2022-10722
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 Other,Health Professional
Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial
Report Date 02/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2022
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 NumberN12211101 0104
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/03/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/21/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/28/2021
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: 03/23/2022 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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