MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC FORCE FEEDBACK; FORCE FEEDBACK MEGA SUTURECUT NEEDLE DRIVER

Model Number	476309-17
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2025
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 central processing, the shaft of the force feedback mega suturecut needle driver broke at the head of the instrument.There was no report of patient involvement.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument broke while being cleaned in the sterile processing department.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The force feedback mega suturecut needle driver was analyzed and the main tube holder was found to be broken.The broken regions measure approximately 1.53 mm x 1.36 mm and 1.09 mm x 1.44 mm in size.The fragments were not returned along with the instrument.Further investigation confirmed additional observations.Upon visual inspection, the main tube was found to be dislodged from its normal position.The instrument was found to have a bent inner tube.The bending damage is located at the proximal end of the inner tube.The complaint was confirmed by failure analysis, which indicates that the device may have contributed to the customer reported issue.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
The instrument was transferred to engineering for further investigation and the initial findings were confirmed.The instrument was confirmed to have a broken main tube holder.It was additionally observed that the chassis - 1 - was broken; the t-tab located on the bottom part of the chassis was broken.A piece of the chassis measuring approximately 6.38mm x 2.85mm was broken off and not returned with the instrument.As a result of the broken chassis t-tab and main tube holder, the main tube assembly was found to be dislodged from its normal position.It was confirmed that the inner tube was also bent and as a result, the inner tube/main tube could not be straightened.The complaint was confirmed by failure analysis, which indicates that the device may have contributed to the customer reported issue.The probable root cause of a broken main tube holder, broken t-tab of the chassis and the bent inner tube is typically attributed to damage during use or reprocessing.Damage can result from mechanical impact, such as an accidental drop of the instrument, or excessive force applied during handling.The probable root cause of a dislodged main tube holder is attributed to the primary failure of broken main tube and t-tab of the chassis.This issue can be resolved by using an alternate instrument to complete the procedure.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: FORCE FEEDBACK
• Common Device Name: FORCE FEEDBACK MEGA SUTURECUT 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: 22058270
• Report Number: 2955842-2025-21097
• Device Sequence Number: 12881330
• Product Code: NAY
• UDI-Device Identifier: 00886874125601
• UDI-Public: (01)00886874125601(11)250203(10)U10250203
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K243641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/12/2025

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: 476309-17
• Device Catalogue Number: 476309
• Device Lot Number: U10250203 0152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/12/2025
• Supplement Date Received by Manufacturer: 05/22/2025; 06/11/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 06/07/2025; 06/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2025
• 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: Unknown
• 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