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

Model Number	420207-10
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.Failure analysis investigations confirmed, the customer reported complaint of failed intuitive motion.The instrument was placed and driven on an in-house system.The instrument passed the recognition and engagement tests.This instruments grip tips were not moving intuitively.They were not following the master tool manipulator (mtm) input commands smoothly.The grips tips were able to open and close properly.However, the yaw and pitch motions appeared be non-intuitive.Instrument was re-tested on a system and confirmed, that output motion wrist was not intuitive and did not correspond to input motion at masters.It was observed, that the roll gear was misaligned by 90 degrees compared to a known good instrument.The roll gear was removed and re-installed in the correct orientation, and this fixed the non-intuitive motion issue upon re-testing.Non-intuitive motion was related to and attributed to the roll gear misalignment.It was also observed, that if the main tube is manually rotated past the roll gear hardstop.The roll gear can pop out of the instrument, causing possible misalignment if re-inserted in a random orientation.
Event or Problem Description
It was reported, during a da vinci-assisted myomectomy surgical procedure.The tip of the tenaculum forceps instrument did not adjust well.The site removed/reseated the drape.However, the issue did not resolve.The procedure was completed with a backup instrument.And there was no reported injury.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: TENACULUM 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: 17067327
• Report Number: 2955842-2023-15725
• Device Sequence Number: 6129980
• Product Code: NAY
• UDI-Device Identifier: 00886874111659
• UDI-Public: (01)00886874111659(10)N10191111
• 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,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/06/2021

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: 420207-10
• Device Catalogue Number: 420207
• Device Lot Number: N10191111 999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2021
• Initial Report FDA Received Date: 06/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2019
• 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: Initial
• 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: Female