MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST SP; NEEDLE DRIVER

Model Number	430006-52
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the claim against the product by the customer noting movement issues with the needle driver, an investigation is in progress.Additional information is being gathered to determine the contribution of the device to the customer reported issue.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the needle driver did not function correctly.The scrub technician stated that the arm did not function correctly.There was an non-intuitive movement and grip with the instrument.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the customer to confirm that the issue occurred with the surgeon console¿s high resolution stereo viewer.The surgeon was attempting to manipulate instruments from the surgeon console.There was no instrument collision or arm interference.A peel packed instrument was used to resolve the issue.No drape information was recorded.No unusual damage was found.

• Brand Name: ENDOWRIST SP
• Common Device Name: NEEDLE DRIVER
• 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: 17149077
• Report Number: 2955842-2023-16409
• Device Sequence Number: 5386833
• Product Code: NAY
• UDI-Device Identifier: 00886874114308
• UDI-Public: (01)00886874114308(10)S10210825
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K182371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/19/2023

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: 430006-52
• Device Catalogue Number: 430006
• Device Lot Number: S10210825 0028
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 06/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2021
• 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: Unknown