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

Model Number	430006-57
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted benign hysterectomy surgical procedure, the needle driver instrument was moving in the opposite direction.The instrument was used on patient side manipulator (psm) 3.An intuitive surgical, inc.(isi) technical support engineer (tse) reviewed the system logs and noted errors 31009/23300 on the instrument sensor missing on psm3 and tool engagement failure on the psm 3, disc 1 was not engaged.The tse recommended customer to reseat the sterile adapter and instrument or try a new instrument.The customer stated that the surgeon started working again and it seemed like it was working as expected at the time of the call.The customer later called back and stated that they replaced the instrument with no change.The tse suggested to reseat sterile adapter which customer performed with no change.The customer confirmed that it was better after instrument replacement.The procedure was completed with no reports of patient injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the da vinci product to perform failure analysis.The needle driver instrument was analyzed, and failure analysis investigation did not confirm nor replicate the customer reported complaint.The instrument was placed and driven on an in-house system.The instrument passed the recognition and engagement tests.The instrument moved intuitively with full range of motion in all directions.The grip opened and closed properly.The instrument was fully functional.No product issue was identified.Additional observation(s) not related to the customer reported complaint was also identified: the needle driver instrument was found to have mechanical indentations/burrs at the grip tips.Intuitive surgical, inc.(isi) also received the patient side manipulator involved with this event to perform failure analysis.The psm was tested on an in-house system and started up in normal mode without triggering any errors or faults.The psm was tested for engagement and driven around, and the unit had functioned as expected with no issues.The psm passed all other tests.

• 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: 18428695
• Report Number: 2955842-2023-21850
• Device Sequence Number: 18075381
• Product Code: NAY
• UDI-Device Identifier: 00886874114308
• UDI-Public: (01)00886874114308(10)U10220502
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/07/2023

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: 430006-57
• Device Catalogue Number: 430006
• Device Lot Number: U10220502 0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2023
• Initial Report FDA Received Date: 01/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2022
• 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: Female