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

Model Number	420172-18
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has requested that the maryland bipolar forceps instrument be returned for failure analysis testing.As of the date of this report, the product has not yet been received.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure there was no energy during use, insulator failure regarding the maryland bipolar forceps instrument.On 10/30/2024, isi followed up with the customer and gathered the following information: the thermal damage was first observed intraoperative during use.There was no arcing during the procedure but there was smoke.There was no injury to the patient.The instrument was inspected prior to use with no abnormality.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.Failure analysis found the primary finding of cannot verify external event to be related to the customer reported complaint.The instrument was placed and driven on an in-house system.The instrument passed energy recognition 2 of 2 attempts.The instrument passed the recognition and engagement tests.The instrument moved intuitively with full range of motion in all directions.The grips opened and closed properly.The instrument released energy 3 of 3 attempts.The instrument was fully functional.No product issue was identified.Issues related to instrument errors or complications using the instrument reported by the user with no underlying product issue may be related to customer-induced problems, including misuse of the product and recognition issues.Additional observation(s) not reported by site: the instrument was found to have charring and localized melting on the bipolar yaw pulley at the base of the grip.As a result of the damage, a section of the active electrode (grip) is exposed that would not normally be exposed.The instrument grips were manually manipulated, and the instrument passed an electrical continuity test on 3 out of 3 attempts.The instrument was placed and driven on an in-house system.The instrument delivered energy with signs of arcing on 3 of 3 attempts.A review of the procedure logs indicated that a monopolar instrument was used during this case.The complaint was not confirmed by failure analysis.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: MARYLAND BIPOLAR FORCEPS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 20720066
• Report Number: 2955842-2024-22067
• Device Sequence Number: 6489602
• Product Code: NAY
• UDI-Device Identifier: 00886874111475
• UDI-Public: (01)00886874111475(10)K10230615
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2024

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: 420172-18
• Device Catalogue Number: 420172
• Device Lot Number: K10230615 198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2024
• Supplement Date Received by Manufacturer: 11/19/2024
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 12/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2023
• 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: Prefer Not To Disclose