MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; MONOPOLAR CAUTERY

Model Number 420142-09

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/05/2022

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) has requested that the monopolar cautery instrument be returned for evaluation, but it has not yet been returned.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.No image or video of the procedure was provided for review.Verification of the event details via system logs cannot be performed at this time because there is insufficient instrument information.This complaint is considered a reportable malfunction event due to the following conclusion: it was alleged that the monopolar cautery instrument tip was burnt.The burned tip has 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.Blank mdr fields: follow-up was attempted, but the missing patient was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.Field is blank because the product is not implantable.Information for the blank fields is not available.Fields are not applicable.

Event Description

It was reported that during a da vinci-assisted surgical procedure, the monopolar cautery instrument tip was burnt.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information on (b)(6) 2022: the monopolar cautery instrument was inspected prior to use and no issues were noted.There was no arcing observed.The pin gauge was used to inspect the cannula.The monopolar cord was connected to a bipolar instrument.Covidien forcefx generator was used with setting 20 for cut and coag.The monopolar cautery instrument tips did not collide with any other instrument or tool during procedure and did not touch any staples, clips or sutures while energized.The instrument jaws were not immersed in liquid or contaminated by carbonized tissue (bio debris) prior to activating the instrument.There was no patient injury and patient has not returned to the hospital due to experiencing any post-surgical complications as a result of the arcing event.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the monopolar cautery instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) investigations replicated/confirmed the customer reported complaint.Fa found the primary failure of hook/spatula melted tip be related to the customer reported complaint.During visual inspection, the monopolar cautery instrument was found to have thermal damage at the tip and the instrument passed an electric continuity.The instrument was placed and driven on an in-house system.The monopolar cautery instrument passed the recognition an engagement tests.The settings used on the generator was 20 for cutting and 20 for coagulation to match the settings stated in the complaint.The instrument released energy and no arcing was observed.The root cause was attributed to mishandling/misuse.An additional observation related to customer reported complaint were also identified.Visual inspection revealed the monopolar cautery instrument had thermal damage to the distal end of the main tube.The root cause was attributed to mishandling/misuse.

• Brand Name: ENDOWRIST;DAVINCI SI
• Type of Device: MONOPOLAR CAUTERY
• 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 Key: 14940346
• MDR Text Key: 295396282
• Report Number: 2955842-2022-12798
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119136
• UDI-Public: (01)00886874119136(10)T10210104
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K050369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420142-09
• Device Catalogue Number: 420142
• Device Lot Number: T10210104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES.
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian