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

Model Number	478115-03
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that during a da vinci-assisted subtotal gastrectomy surgical procedure, the wristed needle driver (wnd) had a broken wire.No fragment fell inside the patient.The procedure was completed as planned with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument was inspected prior to use with no issue.Suture was being performed when the issue occurred.The instrument did not collide with other instrument or tool during the procedure.There was no fragment falling into the patient¿s anatomy.The customer used a backup instrument to continue with the procedure.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the wristed needle driver instrument involved with this complaint and completed the device evaluation.Failure analysis replicated and confirmed the reported complaint.The instrument was found to have a frayed snake wrist cable.The wrist cover was removed for inspection and the cable appeared to be frayed at the distal end.

• 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: 18548606
• Report Number: 2955842-2024-10514
• Device Sequence Number: 20760359
• Product Code: NAY
• UDI-Device Identifier: 00886874113752
• UDI-Public: (01)00886874113752(10)T10230414
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/01/2024

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: T10230414 0025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/01/2024
• Supplement Date Received by Manufacturer: 04/16/2024
• Initial Report FDA Received Date: 01/20/2024
• Supplement Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2023
• 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