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

Model Number	420142-09
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.Failure analysis investigations confirmed the customer reported complaint.Thermal damage was found at the grip adapter assembly where a spatula or hook accessory would be connected the distal end.Black melted char marks were observed.Any material missing is likely to be thermally induced rather than mechanically induced.Failure analysis found the primary failure of a damaged grip adapter assembly to be related to the customer reported complaint.Root cause is attributed to mishandling / misuse.Event verification was performed.Per the review, the following was confirmed: the logs confirmed that the customer performed a oropharyngeal tumor resection on (b)(6) 2022 on system sh1153.A review of the instrument log for the fenestrated bipolar forceps instrument (pn# (b)(4) / lot# t10201204-524) associated with this event has been performed.Per logs, the instrument was last used on (b)(6) 2022 on system sh1153 for approximately 20 minutes.The alleged event occurred on the 15th use of the instrument.This complaint is considered a reportable malfunction due to the following conclusion: thermal damage was found at the grip adapter assembly.Thermal damage at the grip adapter 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.
Event or Problem Description
It was reported that prior to a da vinci-assisted radical tonsillectomy surgical procedure, the tip of monopolar cautery was found to be broken.A backup instrument of the same type was used and 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).Follow-up has been performed to request additional information related to the event.However, no further details have been received as of the date of this report.

• Brand Name: ENDOWRIST;DAVINCI SI
• 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: 14810906
• Report Number: 2955842-2022-12388
• Device Sequence Number: 4677540
• Product Code: NAY
• UDI-Device Identifier: 00886874119136
• UDI-Public: (01)00886874119136(10)T10201204
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/25/2022

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: T10201204 524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/25/2022
• Initial Report FDA Received Date: 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2020
• 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