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

Model Number	476093-17
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The force feedback prograsp forceps instrument was analyzed and failure analysis investigations were able to replicate and confirm the reported issue.The instrument was found to have the grip axis pin dislodged from the grips.The pin was returned with the instrument.The pin's outer diameter measures approximately 0.063" at the swaged end compared to the nominal pin diameter of 0.061".Measurement results suggest the pin is partially swaged.Grips and other components adjacent to the dislodged pin do not show damage.
Event or Problem Description
It was reported that during a da vinci-assisted radical prostatectomy (with lymphadenectomy) surgical procedure, the tip of the force feedback prograsp forceps came apart.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 tip became loose.There was a part at the tip that became loose and then the instrument jaws became limp.The customer did not have additional information on what part of the instrument became loose.No instrument part came completely loose or detached and nothing fell from the instrument.There were no fragments.
Additional Manufacturer Narrative
The force feedback prograsp forceps instrument, which had five out of six uses remaining, was analyzed and found that the root cause of the tip coming apart was attributed to a manufacturing defect with the swaged pin design.The instrument has a broken weld at the distal bushing.Damage to bushing is unrelated to the reported complaint.Effect of damage is imprecise roll motion, although this was not tested in-house due to the protruding grip axis pin.
Event or Problem Description
Refer to h11 for follow-up information.

• 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: 22379912
• Report Number: 2955842-2025-28486
• Device Sequence Number: 21228159
• Product Code: NAY
• UDI-Device Identifier: 00886874125595
• UDI-Public: (01)00886874125595(11)250218(10)U10250218
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Report Date (Section B): 12/29/2025

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: 476093-17
• Device Catalogue Number: 476093
• Device Lot Number: U10250218 0196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/09/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2025
• 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: 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 Age: 53 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White