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

Model Number	476093-17
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The force feedback prograsp forceps (ffpf) instrument was analyzed and found to have the grip axis pin dislodged from the grips.The pin was returned with the instrument.The pin outer diameter measures approximately 0.043" at the swaged end compared to the nominal pin diameter.Measurement results suggest the pin was not swaged at all.Grips and other components adjacent to the dislodged pin do not show damage.The complaint was confirmed by failure analysis, which indicates that the device may have contributed to the customer reported issue.The probable root cause is attributed to the manufacturing process.This pin can become dislodged and sticking out due to improper swaging.This issue can be resolved by using an alternate instrument to complete the procedure.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the customer experienced difficulty removing the force feedback prograsp forceps (ffpf) instrument from one of the arms because a pin was dislodged and prevented the instrument from retracting through the cannula.The customer manually pushed the pin back into place and was then able to remove the instrument from the cannula.The procedure was completing as planned with no reported injury.

• 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: 25210413
• Report Number: 2955842-2026-25536
• Device Sequence Number: 13364405
• Product Code: NAY
• UDI-Device Identifier: 00886874125595
• UDI-Public: (01)00886874125595(11)250709(10)U11250709
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/18/2026

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: U11250709 0060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2025
• 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: Initial
• 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