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	05/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the prograsp forceps instrument made movements in the opposite directions from what was indicated/intended by the surgeon.The site restarted the system and repositioned the system arm with no change.The site then replaced the instrument to resolve the problem and continue with the procedure.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to investigate the reported problem.The isi fse was unable to reproduce the reported non-intuitive motion with the system alone.Isi then received the prograsp forceps instrument involved with this complaint and completed the device evaluation.Failure analysis confirmed the customer reported problem.The instrument was driven on a da vinci in-house system, but intuitive motion was not being experienced.The movement output was not corresponding to what the hand motion was exhibiting at the master tool manipulator (mtm).Failure analysis found the primary failure of a non intuitive motion to be related to the customer report complaint.No cable damage was observed at the wrist assembly or back end.The back of the instrument chassis was observed to have the roll gear oriented in an incorrect position when manually manipulated starting position.The roll gear was removed and no damages were found on the gear or the tabs.The cause of the slippage is due to the roll feature of the instrument going beyond its limitations.

• 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: 17067320
• Report Number: 2955842-2023-15717
• Device Sequence Number: 17674509
• Product Code: NAY
• UDI-Device Identifier: 00886874111345
• UDI-Public: (01)00886874111345(10)N10200204
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/27/2021

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: 420093-14
• Device Catalogue Number: 420093
• Device Lot Number: N10200204 378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 06/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2020
• 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: Unknown
• 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