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

Model Number	420093-14
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, that during a da vinci-assisted radical salvage prostatectomy surgical procedure.The prograsp forceps instrument showed an inversion of rotation, yaw and tilt.The procedure was completed with no reported injury using a backup prograsp forceps.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the prograsp forceps instrument and completed the device evaluation.Failure analysis confirmed, the customer reported complaint and found the instrument's grip-tips to move unintuitively.The instrument was found to be moving in the opposite directions of the surgeon side console (ssc) master tool manipulator (mtm) commands.The instrument's housing was removed and the roll gear was found to be misaligned.The roll gear was removed and reinserted in the correct orientation, which allowed the instrument to pass the intuitive motion test.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: PROGRASP 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: 17067318
• Report Number: 2955842-2023-15716
• Device Sequence Number: 17674508
• Product Code: NAY
• UDI-Device Identifier: 00886874111345
• UDI-Public: (01)00886874111345(10)N10211129
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/28/2022

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: 420093-14
• Device Catalogue Number: 420093
• Device Lot Number: N10211129 955
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 06/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2021
• 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: Male