MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SINGLE-SITE; DAVINCI SI; WRISTED NEEDLE DRIVER

Model Number	428115-02
Medical Device Problem Codes	Unintended System Motion (1430); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the wrist needle driver was found to have the tip tight, and the movement was not smooth when moving.The same instrument was used to continue the surgery.There was no report of fragments falling inside the patient.The procedure was converted to laparoscopic surgery with no report of patient harm, adverse outcome, or injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the surgeon had a back-up instrument but wanted to convert to laparoscopic surgery.There was no other reason to convert the procedure.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the wristed needle driver instrument involved with this complaint and completed the device evaluation.Failure analysis investigations did not replicate nor confirm 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 retested and passed on both attempts.The instrument was fully functional.The housing was removed for inspection and found no damage.There was no problem detected.

• Brand Name: SINGLE-SITE; DAVINCI SI
• Common Device Name: WRISTED 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: 17028345
• Report Number: 2955842-2023-15249
• Device Sequence Number: 12515611
• Product Code: NAY
• UDI-Device Identifier: 00886874112113
• UDI-Public: (01)00886874112113(10)T10190718
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K141075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/24/2021

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: 428115-02
• Device Catalogue Number: 428115
• Device Lot Number: T10190718 087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2019
• 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: Female
• Patient Weight: 61 KG
• Patient Race: Asian