MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; MICRO BIPOLAR FORCEPS

Model Number	470171-14
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during central processing, the micro bipolar forceps instrument was inspection and a brown rust-like liquid leaked from the tip and adhered to the insulation.The customer stated that the instrument was normal during the last procedure usage.There was no report of patient involvement.Isi followed up with the initial reporter and obtained the following additional information: the instrument did not exhibit any unintended energy discharge.The instrument involved in inadvertent contact with another hard object or instrument during the procedure.The instrument was inspected before central processing.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the micro bipolar forceps instrument for failure analysis.Inspection found a brownish-rust like residue on the bipolar yaw pulley.Additional inspection found localized melting near the grip base.This observation is unrelated to the primary issue.Thermal damage is attributed to carbonized tissue on the grips of this bipolar instrument creating a conductive path during use.Thermal damage can also result due to inadvertent energy application from a monopolar instrument.The instrument was placed and driven on an in-house system.The instrument passed the recognition, engagement, energy delivery and electrical continuity tests.The instrument moved intuitively with full range of motion in all directions.The grips opened and closed properly.The complaint was confirmed by failure analysis, which indicates that the device may have contributed to the customer reported issue.
Additional Manufacturer Narrative
Additional analysis was performed on the micro bipolar forceps instrument by an advanced failure analysis engineer (afae).The initial findings were confirmed.The localized melting near the grip bases can be categorized as thermal damage.Fae attempted to transfer the brown rust-like debris from the instrument to fourier-transform infrared spectroscopy (ftir) crystal by scraping off with a pair of tweezers and wiping with a cotton swab and alcohol but neither worked, so the compositional analysis could not be performed.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST
• Common Device Name: MICRO 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: 18378869
• Report Number: 2955842-2023-21457
• Device Sequence Number: 12693435
• Product Code: NAY
• UDI-Device Identifier: 00886874112274
• UDI-Public: (01)00886874112274(10)N10180131
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K131861
• 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): 11/29/2023

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: 470171-14
• Device Catalogue Number: 470171
• Device Lot Number: N10180131 0047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/15/2024
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 03/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2018
• 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