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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); Arcing (2583)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/14/2021
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the instrument involved with this complaint and completed the device evaluation. 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 appear to be compromised and the conductor wire thermally damaged around the weld location. Any material missing is likely to be thermally induced rather than mechanically induced. Failure analysis found the primary failure of broken conductor wire at the weld to be related to the customer reported complaint. Root cause is attributed to a device design. Additional observation not reported by the site was that the instrument was found have thermal damage of the monopolar yaw pulley. Black char marks were observed. Any material missing is likely to be thermally induced rather than mechanically induced. Failure analysis found the additional failure of thermal damage of the monopolar yaw pulley-weld damage to be related to the customer reported complaint. Root cause is attributed to a device design. A site history complaint review was performed and no related complaints were found to the product. A system log review confirmed the permanent cautery hook was last used on (b)(6) 2021 on (b)(4) with 4 uses remaining. The permanent cautery hook is intended to be used with the da vinci system for precise dissection and division of tissue with monopolar cautery. The instrument is designed to provide energy from the designated location on the instrument (the tip) to the planned anatomical location when used as intended. The energy is activated by pressing the designated pedal on the surgeon side console (ssc). This complaint is reportable due to the following conclusion: there was evidence of thermal damage to the weld with no indication or claim of user mishandling or misuse. 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.
 
Event Description
It was reported that the permanent cautery hook instrument caught on fire and smoked during a da vinci-assisted cholecystectomy surgical procedure. The procedure was completed with no patient harm. Intuitive surgical inc. (isi) followed up with the customer and obtained the following additional information on 28-june-2021. It was confirmed that there was no patient harm, including no harm to the surround tissue. The customer clarified that by "fire" they meant that they saw sparks coming from the instrument. A replacement cautery hook instrument was used to continue and complete the procedure. No other details related to the event and no patient-related information was available.
 
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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 Key12204038
MDR Text Key262692197
Report Number2955842-2021-10836
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
Reporter Occupation Non-Healthcare Professional
Remedial Action Other
Type of Report Initial
Report Date 06/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2021
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 NumberN10210104 0178
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/09/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/25/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/17/2020
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: 07/21/2021 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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