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

Model Number	420049-09
Medical Device Problem Codes	Unintended System Motion (1430); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the claim against the product by the customer noting the cadiere forceps lost control, an investigation is in progress to determine the cause of this reported event.A return material authorization (rma) has been issued and intuitive surgical, inc.(isi) has requested to have the cadiere forceps instrument be returned for evaluation; however, the instrument has not yet been received as of the date of this report.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the product is returned and evaluated and/or if additional information is received.
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, the cadiere forceps instrument lost control.A backup instrument of the same kind was used.The procedure was completed 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.
Event or Problem Description
Refer to h10/h11 for follow-up information.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the cadiere forceps instrument did not move by itself, only the surgeon could no longer move it in a certain position due to the failure, it remained stationary without generating any risk to the patient.The issue occurred with the surgeon¿s head inside the surgeon console¿s high resolution stereo viewer while the surgeon was attempting to manipulate instruments from the surgeon console.The instrument remained static.Instrument movement scaled appropriately, moved in the intended direction, with appropriate timing.There was no shakiness/friction observed.The customer was unable to tell if there was instrument or arm interference.There were no collisions.The issue was persistent.The surgeon was attempting to take usual movements with the instrument.The instrument was replaced to resolve the issue.The safety wrench was used to remove the defective instrument.There was no injury to the patient.The instrument was inspected prior to use and nothing out of the ordinary was noted.
Additional Manufacturer Narrative
This supplemental mdr was created to provide follow up information received from the customer.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the da vinci product to perform failure analysis.The cadiere forceps instrument was analyzed, and failure analysis investigations did not replicate nor confirm the customer reported complaint.The instrument was placed and driven on an in-house system.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.Failure analysis also found additional observations not reported by site that are not related to the customer reported complaint: after opening the housing, the instrument was found to have a derailed grip cable at the proximal clamping pulley.The yaw motion may be non-intuitive as a result.The instrument was found to have a broken input shaft.The top of the input shaft broke off.This is the input the instrument release kit (irk) was used on.The instrument was found to have signs of damage to the irk port of the housing.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
The cadiere forceps instrument was transferred to engineering for further analysis and the initial findings were confirmed.The instrument release key port damage on the instrument housing was closely reviewed.It appeared that the housing material in the area was pushed in as if some kind of object hit the area.The customer stated that the "safety wrench" was used to remove the instrument, likely referring to the irk.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: CADIERE 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: 17136539
• Report Number: 2955842-2023-16352
• Device Sequence Number: 3941731
• Product Code: NAY
• UDI-Device Identifier: 00886874111338
• UDI-Public: (01)00886874111338(10)N10171024
• 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,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/22/2023

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: 420049-09
• Device Catalogue Number: 420049
• Device Lot Number: N10171024 197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2023
• Supplement Date Received by Manufacturer: 06/21/2023; 07/14/2023; 08/24/2023
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 07/17/2023; 08/04/2023; 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2017
• 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