MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC FORCE FEEDBACK; FORCE FEEDBACK PROGRASP FORCEPS

Model Number	475093-15
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during central processing, there was broken plastic on the shaft of the force feedback prograsp forceps.There was no reported patient impact or harm.
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.A follow-up mdr will be submitted if the instrument is returned (post failure analysis evaluation) or if additional information is received.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The force feedback prograsp forceps was analyzed and found to have a broken main tube approximately 86.15 mm from the end of the distal tip.The break is located at the distal overmolded end of the main tube.A piece, measuring approximately 6.25mm x 5.51mm in size, was not returned with the instrument.Components adjacent to this broken main tube show damage which may indicate potential mishandling/misuse.A bent inner tube was observed.Further investigation confirmed additional observations.Due to the broken main tube, a detached fragment was observed that was not returned with the instrument.The instrument was found to have a bent inner tube approximately 80.22mm from the distal tip.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
This instrument was further analyzed and found complaint involved broken plastic observed on an instrument with 3 of 4 uses remaining.Failure analysis showed main tube (pn (b)(4) damage, inner tube and weld joint damage, consistent with excessive loading from mishandling/user misuse.Log review showed 30 minutes of use.Instrument was found by central reprocessing with no patient impact or harm reported.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 the broken main tube and the detached fragment is attributed to damage during use, which may result from an accidental drop of the instrument or inadvertent collisions with other instruments.Excessive side loading on the instrument can also cause the main tube wall to collapse inwards leading to cracking and subsequent breakage.The probable root cause of the bent instrument inner tube cannot be determined based on the failure analysis.These issues can be resolved by using an alternate instrument to complete the procedure.

• Brand Name: FORCE FEEDBACK
• Common Device Name: FORCE FEEDBACK PROGRASP FORCEPS
• 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: 21024343
• Report Number: 2955842-2024-23682
• Device Sequence Number: 20910596
• Product Code: NAY
• UDI-Device Identifier: 00886874125434
• UDI-Public: (01)00886874125434(10)U10240816
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K232610
• 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): 12/13/2024

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: 475093-15
• Device Catalogue Number: 475093
• Device Lot Number: U10240816 0029
• 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: 12/13/2024
• Supplement Date Received by Manufacturer: 04/18/2025; 10/01/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 04/29/2025; 10/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2024
• 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