MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; DOUBLE FENESTRATED GRASPER

Model Number	420189-12
Medical Device Problem Codes	Unintended System Motion (1430); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the double fenestrated grasper instrument was unable to be removed from the arm and had to be removed with force.The procedure was completed with a backup instrument and there was no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the double fenestrated grasper instrument involved with this complaint and completed the device evaluation.Failure analysis investigation did not confirm the reported failure.Failure analysis found the instrument was installed and removed several times from the systems arm with no issues.The instrument passed the recognition and engagement tests when it was placed and driven on an in-house system.This instruments grip tips were not moving intuitively, i.E.They were not following the surgeon side console (ssc) master tool manipulator (mtm) input commands smoothly.The instrument was transferred to engineering for further evaluation.The instrument was re-tested on in-house system and non-intuitive motion was confirmed.Grips opened/closed properly, but pitch and yaw motions at wrist were opposite of the mtm commands.After removing the instrument, it was observed that the main tube orientation at the "home position (initial orientation upon completion of instrument engagement) was off by nearly 180 degrees compared to a known good instrument.With instrument main tube manually rotated to home position, the roll gear tab was confirmed to be in a different location compared to a known good instrument.Roll gear was able to be removed and re-installed to correct orientation, and it was confirmed that this resolved the non-intuitive motion.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: DOUBLE FENESTRATED GRASPER
• 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: 17067239
• Report Number: 2955842-2023-15664
• Device Sequence Number: 12434635
• Product Code: NAY
• UDI-Device Identifier: 00886874111581
• UDI-Public: (01)00886874111581(10)N10190502
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 09/24/2020

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: 420189-12
• Device Catalogue Number: 420189
• Device Lot Number: N10190502 297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 06/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2019
• 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: 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