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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 Smoking (1585)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/15/2021
Event Type  malfunction  
Event Description
It was reported that during a da vinci-assisted myomectomy surgical procedure, the permanent cautery hook (pch) instrument was found to have smoke generated from behind and not from the instrument tip. A backup instrument was used to continue the procedure. There was no report of fragments falling inside the patient. The procedure was completed with no report of patient injury. Intuitive surgical, inc. (isi) followed up with the initial reporter and obtained the following additional information: the instrument was inspected prior to use with no damage observed. There was no patient injury/harm. The customer confirmed that no fragment fell inside of the patient. The instrument was in use for cauterizing for about 10 minutes, then smoke was generated from behind the instrument tip. Arcing was not observed. Monopolar coagulation energy was activated with a 3rd party generator. The settings used on the generator was 50 for cutting and 50 for coagulation. The monopolar cord was not connected to a bipolar instrument. In addition, the instrument tips did not collide with any other instrument or tool during procedure. The instrument tips were not in contact with tissue and did not touch any staples, clips or sutures. The jaws were not immersed in liquid or contaminated by carbonized tissue (bio debris) prior to activating the instrument. The instrument was not removed at any time. The patient has not returned to the hospital due to any post-surgical complications. Photographic images of the device or a video recording of the procedure were not available for isi review. Although requested, the following information is unknown: if the cannula was inspected prior to use, if other instruments were in use, and what caused the event along with information regarding patient demographics, relevant testing, and medical history.
 
Manufacturer Narrative
Intuitive surgical, inc. (isi) has not received the permanent cautery hook instrument for evaluation. Therefore, the root cause of the customer reported failure mode has not been determined. A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received. A review of the site's complaint history does not show any additional complaints related to this product and/or this event. In addition, a review of the instrument log for the permanent cautery hook (pch) (part # 420183-15/lot# n10210531 039) associated with this event has been performed. Per logs, the instrument was last used on (b)(6) 2021, on system (b)(4). The instrument had 6 uses remaining after last use. No image or video clip for the reported event was submitted to isi for review. This event is being reported because the permanent cautery hook instrument smoked with no evidence or claim of user mishandling or misuse. The allegation could be related to the potential for 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.
 
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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 Key13318273
MDR Text Key284214864
Report Number2955842-2022-10111
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K050369
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 12/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/21/2022
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 NumberN10210531 0039
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/26/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/27/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/27/2021
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: 01/21/2022 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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