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

Model Number	420143-06
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that during a da vinci-assisted thyroidectomy surgical procedure, the maryland dissector instrument moved in an unintended way for three times in an hour.Based on the claim against the product by the customer noting the maryland dissector instrument moved in an unintended way, an investigation was completed to determine the cause of this reported event.An rma was issued to the customer requesting to have the intuitive surgical, inc.(isi) device returned.Additional information is being gathered to determine the contribution of the device to the customer reported issue.Isi reviewed the site¿s complaint history, which did not show any additional complaints related to this product and/or this event.A review of the instrument log for the maryland dissector instrument (part# 420143-06| lot/serial# (b)(4) associated with this event has been performed.Per this review of the logs, the maryland dissector instrument was last used on (b)(6) 2022 via system sh2009.There were 6 uses remaining after this last usage.A review of the rfe procedure log showed the site performed this thyroidectomy surgical procedure on (b)(6) 2022 via system sh2009.The investigation to determine the cause of this reported event is currently in progress.As such, the probable root cause cannot yet be determined based on the information provided.Complaints are tracked via the qms processes.This complaint is considered as a reportable malfunction due to the following conclusion: it was alleged that the maryland dissector instrument moved with unintuitive motion and in an unintended way.Unintuitive motion could lead to subsequent tissue damage.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 during a da vinci-assisted thyroidectomy surgical procedure, the maryland dissector instrument was unresponsive to the surgeon's commands.The instrument moved in the other direction than intended for 3 times in an hour.A backup instrument of same kind was used to continue the procedure and the issue did not reoccur.There was no report of fragment(s) falling inside the patient.The procedure was completed with no report of patient injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument was inspected prior to use with no abnormality.The customer confirmed that the issue occurred one hour after the start of the procedure while the surgeon¿s head was inside the surgeon console¿s high resolution stereo viewer and the surgeon was attempting to manipulate instrument.There was no shakiness, friction, and/or external collisions occurred.The timing of instrument movement was appropriate without delay/lag.There was no injury to the patient as result of the event.The lot number of the drape was unknown and the drape would not be returned.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
Based on the claim against the product by the customer noting the instrument moved in an unintended way, an investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The maryland dissector instrument was analyzed and the complaint regarding unintuitive motion was not confirmed by failure analysis.Failure analysis could not verify the external event.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.The instrument was fully functional and 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.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: MARYLAND DISSECTOR
• 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: 15891285
• Report Number: 2955842-2022-15658
• Device Sequence Number: 6793443
• Product Code: NAY
• UDI-Device Identifier: 00886874111413
• UDI-Public: (01)00886874111413(10)S10160201
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 11/02/2022

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: 420143-06
• Device Catalogue Number: 420143
• Device Lot Number: S10160201 599
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/02/2022
• Supplement Date Received by Manufacturer: 12/13/2022
• Initial Report FDA Received Date: 11/30/2022
• Supplement Report FDA Received Date: 01/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2016
• 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