MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; PRECISE BIPOLAR FORCEPS

Model Number	420110-12
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted radical prostatectomy without lymphadenectomy surgical procedure, the precise bipolar forceps (pbf) instrument had a poor recognition issue.The instrument was cleansed, and sterile adapter was reattached, but the issue was not resolved.The procedure was completing as planned 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.
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive the precise bipolar forceps (pbf) instrument to perform failure analysis.The instrument was analyzed, and the complaint of poor recognition was not confirmed by failure analysis.The instrument was placed and driven on an in-house system and passed the recognition and engagement tests.The instrument moved intuitively with full range of motion in all directions.The grips opened and closed properly.There were no logs available during testing.Additional observations, which were not reported by site: the instrument was found to have localized melting near the grip base.The instrument passed the energy delivery and electrical continuity tests.The instrument was also found to have dried residue around the clamping pulley cable groove.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: it was stated that the precise bipolar forceps instrument was not used during the radical prostatectomy procedure on (b)(6) 2023.There was no known functional issue during the previous procedure usage involving the instrument.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: PRECISE BIPOLAR FORCEPS
• 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: 17997226
• Report Number: 2955842-2023-19548
• Device Sequence Number: 6520215
• Product Code: NAY
• UDI-Device Identifier: 00886874111352
• UDI-Public: (01)00886874111352(10)N10210830
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 09/26/2023

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: 420110-12
• Device Catalogue Number: 420110
• Device Lot Number: N10210830 989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2023
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/26/2023
• Supplement Date Received by Manufacturer: 10/26/2023
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 11/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2021
• 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: Male