MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; FORCE BIPOLAR

Model Number	470405-06
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the da vinci product to perform failure analysis.The force bipolar instrument was analyzed and the instrument was found to have corrosion on one or more clamping pulleys in the backend.Additional observation related to the customers complaint: the instrument was found to have a derailed grip cable at the distal end.The instrument was found to have a frayed grip cable at the grip hub, but the cable is not fully broken.The frayed cable strands stuck out at the wrist.Further inspection found no abnormally sharp or damaged components that could have contributed to the cable breaking.Common causes of the failure mode corroded/contaminated instrument clamping pulleys are typically attributed to the user.For example this could be by improper cleaning or sterilization techniques used in reprocessing, which may include prolonged exposure of the instrument to harsh cleaning agents or insufficient flushing.Common causes of the failure mode derailed instrument grip cables are attributed to a component failure.Derailed cables are 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 derailed or loose at the distal end, which may lead to non-intuitive motion.Common causes are attributed to damage to the cable through external collisions, during transport/storage, during use, or during reprocessing.
Event or Problem Description
It was reported that during a da vinci-assisted cholecystectomy surgical procedure, the force bipolar instrument jaws were not opening properly.The procedure was completed with no reported injury.Isi followed up with the initial reporter to obtain additional information, however, no further details are available regarding the reported event.

• Brand Name: ENDOWRIST
• Common Device Name: FORCE BIPOLAR
• 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: 24596483
• Report Number: 2955842-2026-15977
• Device Sequence Number: 21130298
• Product Code: NAY
• UDI-Device Identifier: 00886874115930
• UDI-Public: (01)00886874115930(10)N10200824
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K180351
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Remedial Action: Notification,Other
• Type of Report: Initial
• Report Date (Section B): 03/12/2026

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: 470405-06
• Device Catalogue Number: 470405
• Device Lot Number: N10200824 0094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2020
• 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: ISIFA2024-09-C
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES.
• Patient Sex: Unknown