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

Model Number	478115-03
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the wristed needle driver instrument was inserted, but the wire broke right away.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) requested that the wristed needle driver instrument be returned for failure analysis investigation.Isi has not received the da vinci product with an alleged issue to perform failure analysis.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: customer stated that they did not experience any issues with the opening/closing of the grips, the left/right (yaw) motion of the grips or the up/down motion (pitch) of the wrist.There was one protruding cable at the at the distal end of the wrist and it is the one that control the opening and closing of grips.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the da vinci product to perform failure analysis.The wristed needle driver instrument was analyzed and found to have a frayed snake wrist cable at the distal clevis.Some filaments of the cable were frayed, but the cable is not fully broken.The frayed cable strands stuck out at the wrist.There were no evidence of discoloration or corrosion/contamination on the cables to indicate a reprocessing induced issue.Further inspection found no abnormally sharp or damaged components that could have contributed to the cable breaking.The complaint regarding a broken cable was confirmed by failure analysis.
Event or Problem Description
Refer to 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 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 20701209
• Report Number: 2955842-2024-22017
• Device Sequence Number: 20450921
• Product Code: NAY
• UDI-Device Identifier: 00886874113752
• UDI-Public: (01)00886874113752(11)230428(10)T10230428
• 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
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/24/2024

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: T10230428 0051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2024
• Supplement Date Received by Manufacturer: 11/18/2024; 12/17/2024
• Initial Report FDA Received Date: 11/16/2024
• Supplement Report FDA Received Date: 12/12/2024; 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2023
• 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