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

Model Number	470347-17
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/01/2026
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 was observed moving erratically.The procedure was completed with no reported injury.
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 tip-up fenestrated grasper was analyzed and found to have a loose pitch cable at the proximal end.There was no loose screw at the pitch clamping pulley.A visual inspection of the backend found no evidence of a cracked clamping pulley, input disk, or input shaft that would have caused the loose cable.No frayed pitch cable at the distal end.The tip-up fenestrated grasper exhibited imprecise motion during gripping and un-gripping.The instrument was placed and driven on an in-house system.The instrument passed the recognition and engagement tests.The tip-up fenestrated grasper exhibited imprecise motion in the pitch direction.The grip tips moved in the direction commanded, however, a lag or delay in the motion was observed as a result of the loose pitch cable at the proximal end.The probable root cause is attributed to a loss of cable tension.A cracked clamping pulley and/or input shaft can cause the cable to become dislodged at the proximal end.When the clamping pulley and/or input shaft is cracked, the cable can dislodge as the input could "slip" with respect to its internal shaft causing the loss of cable tension.A cracked clamping pulley and/or input shaft can be caused by improper cleaning or sterilization techniques used during reprocessing.A dislodged cable at the proximal end can then result in the cable becoming loose at the distal end.

• 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: 50900400
• Report Number: 2955842-2026-39963
• Device Sequence Number: 6001268
• Product Code: NAY
• UDI-Device Identifier: 00886874112496
• UDI-Public: (01)00886874112496(10)K16260318
• 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): 09/25/2026

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: K16260318 0095
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/11/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2026
• 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