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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 Smoking (1585); Arcing (2583); Sparking (2595)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/13/2021
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) has requested the 8mm permanent cautery hook instrument involved with this complaint to be returned for failure analysis. However, as of the date of this report, the instrument has not been received. A review of the site's complaint history does not show any additional complaints related to this product. Verification of the event details via instrument logs cannot be performed at this time because there is insufficient product information - the instrument sequence number was not provided. No image or video of the procedure was provided for review. Based on the information provided at this time, this complaint is being classified as a reportable event due to the following conclusion: the permanent cautery hook instrument reportedly had sparks & smoke arising from the wrist of the instrument whenever the energy pedals were pressed, with no evidence or claim of user mishandling/misuse. At this time the root cause of the reported damage is unknown as the instrument has not been returned for evaluation. Although there was no report of patient injury, the issue could potentially cause or contribute to an adverse event if it were to recur.
 
Event Description
It was reported that during a da vinci-assisted surgical procedure, the 8mm permanent cautery hook instrument had sparks & smoke arising from the wrist of the instrument whenever the energy pedals were pressed. The procedure was completed with no reported injury. 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 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 Key13303846
MDR Text Key284099279
Report Number2955842-2022-10101
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K131861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign
Reporter Occupation Non-Healthcare Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 12/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/20/2022
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 NumberN11190902 0034
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/26/2022
Date Manufacturer Received01/27/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/29/2019
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: 01/20/2022 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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