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

Model Number	470347-17
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after a da vinci-assisted surgical procedure, the tip up fenestrated grasper instrument would not close.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the da vinci product to perform failure analysis.The tip up fenestrated grasper instrument was analyzed and found to have one severely bent grip, causing misalignment of the grip-tips.There was a 1.50mm offset at the tips.The grips were found to have cracking damage.The instrument was found to have a frayed grip cable at the distal end.Some wires were broken, but the cable itself was not fully broken.There was no discoloration, corrosion, or contamination observed on the cable that would occur from improper flushing or rinsing during reprocessing.Further inspection found no abnormally sharp or damaged components that could have contributed to the cable breaking.The instrument was found to have a partially fractured main tube at the distal end.Components adjacent to this broken main tube show damage which may indicate potential mishandling.There were missing pieces of the broken main tube, but the size of the missing pieces cannot be confirm.The proximal clevis was observed to be dislodged from the main tube interface.Loss of proper engagement between the proximal clevis and the main tube was noted, which may be associated with structural compromise of the main tube.The complaint regarding the instrument would not close was confirmed by failure analysis.The probable root cause can be attributed to damage during either use or reprocessing, as severe misalignment of grip tips can be due to accidental drops, incorrect instrument tray or sink sizes for reprocessing, or overloading the tips by applying excessive force on the jaws.The probable root cause can be attributed to damage during use, which may result from an accidental drop of the instrument or inadvertent collisions with other instruments.

• 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: 50893583
• Report Number: 2955842-2026-39942
• Device Sequence Number: 10706065
• Product Code: NAY
• UDI-Device Identifier: 00886874112496
• UDI-Public: (01)00886874112496(10)K17260312
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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): 09/24/2026

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: K17260312 0210
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/02/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2026
• 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