MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC EndoWrist; TIP-UP FENESTRATED GRASPER

Model Number	470347-17
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	07/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, a tip-up fenestrated grasper instrument became stuck in the patient's chest because the distal end came out of the forceps sheath, the forceps jammed, making it impossible for the surgeon to manipulate it from the robot console.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument was removed by hand.All the parts were still attached to the instrument.No fragment fell into the patient.The procedure was completed using a replacement instrument.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the tip-up fenestrated grasper instrument to perform failure analysis (fa).Fa was able to confirm/reproduce the reported complaint.The instrument was found to have the proximal clevis dislodged.The dislodged proximal clevis is attached to the main tube.The probable root cause is attributed to damage during use.Applying excessive force on the distal end of the instrument during handling, insertion, usage (overloading), or removal can cause damage.Additional related observations: the instrument was found to have a broken main tube at the distal tip, and it was not returned with the instrument.The part that was holding the proximal clevis is missing.Components adjacent to this broken main tube do not show damage.The probable root cause 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 causing it to crack and subsequently break.

• Brand Name: EndoWrist
• Common Device Name: TIP-UP FENESTRATED GRASPER
• 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 ; +1(408)523-2100
• MDR Report Key: 50910822
• Report Number: 2955842-2026-40135
• Device Sequence Number: 5776834
• Product Code: NAY
• UDI-Device Identifier: 00886874112496
• UDI-Public: (01)00886874112496(11)251023(10)K12251023(91)0005
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K131861
• 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): 09/27/2026

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: 470347-17
• Device Catalogue Number: 470347
• Device Lot Number: K12251023 0250
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/10/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2025
• 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