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

Model Number	478115-03
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted myomectomy surgical procedure, the wristed needle driver instrument jaws were not opened due to a broken cable.A backup instrument was used.No known impact or patient consequence was reported.Procedure was completed.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument was inspected prior to use, and no damage was found.The customer indicated that a cable was found protruding from the distal end of the instrument while suturing the tissue and the issue was related to the opening, closing of the grips.The instrument jaw was not grasping on tissue when the issue occurred.There were no issues with left, right motion of the grips or up, down motion of the wrist.The instrument did not collide with any other instrument or tool during the procedure.The procedure was completed with no report of fragment(s) falling inside the patient.
Additional Manufacturer Narrative
An rma was issued to evaluate the intuitive surgical, inc.(isi) device.Additional information is being gathered to determine the contribution of the device to the customer reported issue.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The wristed needle driver instrument was analyzed and found to have one grip cable broken at the proximal end in the housing.The grip cable was broken at the clamping pulley.This caused the jaws not to open.The clamping pulleys did not exhibit signs of corrosion/contamination/residue that would have contributed to the broken cable.No pitch cable damage confirmed.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: SINGLE-SITE
• 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: 18532460
• Report Number: 2955842-2024-10413
• Device Sequence Number: 20520716
• Product Code: NAY
• UDI-Device Identifier: 00886874113752
• UDI-Public: (01)00886874113752(10)T10200311
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K152448
• 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,Followup
• Report Date (Section B): 12/27/2023

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: 478115-03
• Device Catalogue Number: 478115
• Device Lot Number: T10200311 0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/27/2023
• Supplement Date Received by Manufacturer: 04/16/2024
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2020
• 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: 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