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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC ENDOWRIST PERMANENT CAUTERY SPATULA Back to Search Results
Model Number 470184-13
Device Problems Thermal Decomposition of Device (1071); Arcing (2583)
Patient Problem Insufficient Information (4580)
Event Date 11/15/2021
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the 8mm permanent cautery spatula instrument involved with this complaint and completed the device evaluation. Failure analysis (fa) replicated/confirmed the customer reported complaint. Failure analysis found the primary failure of the monopolar yaw pulley thermal damage - sleeve damage to be related to the customer reported complaint. The instrument was found to have thermal damage - sleeve damage at the yaw pulley. The yaw pulley exhibited localized melting at the base of the ceramic sleeve. Additionally, the distal clevis, distal pulleys, proximal clevis, and conductor wire cap exhibited signs of thermal damage from the same source. The conductor wire exhibited signs of insulation damage. The ceramic sleeve was not dislodged or damaged. An electrical continuity was performed and passed. There was no damage at the weld observed. The root cause of these failures are attributed to a component failure. Additional observations not reported by site were also identified. The permanent cautery spatula instrument was found to have a derailed grip cable at the distal idler pulley. The yaw motion may be non-intuitive as a result. The root cause of the derailed grip cables is attributed to a component failure. The instrument was found to have various scratch marks with light material removed on the main tube. The scratch marks were 0. 061¿ - 0. 163" in length and were not aligned with the tube axis. The root cause of the scratch marks /abrasions on the instrument main tube is typically attributed to mishandling/misuse. The instrument was found to have damage of the conductor wire¿ insulation. The internal wires were not exposed and the root cause of this failure is attributed to a component failure. A review of the instrument log for the permanent cautery hook (470184-13/ n102011030004) associated with this event has been performed. Per logs, the permanent cautery spatula instrument was last used on (b)(6) 2021 on system sk0174. The instrument had 3 uses remaining after the last procedural use. A review of the site's complaint history does not show any additional complaints related to this product. No image or video was provided for review. This complaint is being reported due to the following conclusion: the permanent cautery spatula instrument had cautery piece charred with no evidence or claim of user mishandling or misuse. Thermal damage proximal to the ceramic sleeve is evidence of electrical discharge at a location other than intended. 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. Blank mdr fields: follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable. The expiration date is not applicable. Implant date is not applicable because the product is not implantable. Fields pma/510(k) number and adverse event are not applicable.
 
Event Description
It was reported that during a da vinci-assisted benign hysterectomy surgical procedure, the 8mm permanent cautery spatula instrument had charred exposed cautery piece. It is unknown if there was any patient injury and if the procedure was completed or not. Intuitive surgical, inc. (isi) made multiple follow-up attempts to obtain additional information. However, no further details have been received as of the date of this report.
 
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Brand NameENDOWRIST
Type of DevicePERMANENT CAUTERY SPATULA
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 Key12991532
MDR Text Key282179846
Report Number2955842-2021-11733
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 11/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number470184-13
Device Catalogue Number470184
Device Lot NumberN10201103 0004
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/09/2021
Date Manufacturer Received11/19/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/29/2020
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: 12/13/2021 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES.
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