MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; LARGE SUTURE CUT NEEDLE DRIVER

Model Number	420296-02
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted hysterectomy procedure, the large suture cut needle driver instrument was not performing the movements during the incident.The surgical staff observed that the wire was broken.The procedure was completed with no reported injury and with a delay of less than 15 minutes.No fragment fell into the patient.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has requested that the large suture cut needle driver instrument be returned for failure analysis testing.As of the date of this report, the product has not yet been received.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The instrument was analyzed and found to have a broken grip cable at the grip hub location.The cable was fully broken.As a result of the full break, functional testing for motion related issues could not be performed.There was no discoloration, corrosion, or contamination on the cable that would occur from improper flushing or rinsing during reprocessing.Further inspection found no abnormally sharp or damaged components that could have contributed to the cable breaking.The complaint was confirmed by failure analysis.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: LARGE SUTURE CUT 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: 19621472
• Report Number: 2955842-2024-16360
• Device Sequence Number: 8121436
• Product Code: NAY
• UDI-Device Identifier: 00886874111789
• UDI-Public: (01)00886874111789(10)M10120907
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2024

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: Other
• Device Model Number: 420296-02
• Device Catalogue Number: 420296
• Device Lot Number: M10120907 249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2024
• Supplement Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2012
• 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: Prefer Not To Disclose