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

Model Number	420142-09
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Arcing (2583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An intuitive surgical, inc.(isi) has requested the monopolar cautery instrument involved with this complaint be returned but it has not been received yet.Therefore, the root cause of the alleged customer reported failure mode has not been determined.A follow-up mdr will be submitted upon completion of the failure analysis evaluation and if additional information is received.Isi has received the images of the alleged monopolar cautery instrument.The review of the provided image is conducted by the regulatory post market surveillance specialist (rpms) and found that the monopolar cautery instrument tip has burn marks.The root cause of the failure mode cannot be confirmed without the returned device.A review of the instrument logs for the monopolar cautery (part number 420142-09/lot number t10190325 502) associated with this event has been performed.Per the review, the monopolar cautery instrument was last used in a procedure on (b)(6) 2022 on system (b)(4).The alleged instrument had 12 uses remaining after the last procedural use.This complaint is reportable malfunction event due to the following: it was alleged that the monopolar cautery instrument had burn marks.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.
Event or Problem Description
It was reported that during a da vinci-assisted partial nephrectomy surgical procedure, the tip of the monopolar cautery instrument was found to have burn signs.The monopolar cautery spatula instrument and the tip of the monopolar cautery instrument were both slightly burnt.The procedure was completed with no reported injury.The monopolar cautery instrument with the 5 mm cautery hook tip or 5 mm cautery spatula tip is intended to be used with the da vinci sp system for manipulating and dissecting tissue and coagulating and transecting tissue using monopolar electrosurgical energy.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).Isi followed up with the initial reporter and obtained the following additional information on 28-july-2022: the monopolar cautery instrument was inspected prior to use and had no damage.The arcing was observed during procedure and the instrument was found to have burn signs.The cannula was inspected prior to use with a pin gauge.The issue was occurred while dissecting the tissue.Monopolar cut energy was activated when arcing occurred and the monopolar cord was not connected to a bipolar instrument.The forcetriad generator was used with the setting of 20 for cut and coag.The maryland bipolar forceps instrument was used when arcing event occurred and there was no issue with this instrument.The instrument tips did not collide with any other instrument or tool during procedure.The instrument tip(s) were in between in contact with tissue when the event occurred.There was no patient injury and the patient has not returned to the hospital due to post-surgical complications as a result of the arcing event.The monopolar cautery instrument jaws were not immersed in liquid or contaminated by carbonized tissue (bio debris) prior to activating the instrument.There was no grounding location for the arcing, as it could be seen while in air.No tissue was involved in the arcing therefore there was no discoloration of the tissue observed.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the monopolar cautery instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) investigation replicated/confirmed the customer reported complaint.Fa found the primary failure of tube extension thermal damage be related to the customer reported complaint.The tube extension was found to have thermal damage at the tip.The root cause is attributed mishandling/misuse.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST
• Common Device Name: 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: 15254910
• Report Number: 2955842-2022-13515
• Device Sequence Number: 6687706
• Product Code: NAY
• UDI-Device Identifier: 00886874111406
• UDI-Public: (01)00886874111406(10)T10190325
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 420142-09
• Device Catalogue Number: 420142
• Device Lot Number: T10190325 502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2022
• Supplement Date Received by Manufacturer: 08/19/2022
• Initial Report FDA Received Date: 08/18/2022
• Supplement Report FDA Received Date: 09/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian