MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; PERMANENT CAUTERY SPATULA

Model Number	420184-11
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the 8mm permanent cautery spatula (pcs) instrument was not flexible in the wrist rotation and the instrument wire slipped.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 surgeon was cutting the uterine ligament when the issue occurred.The failure was related to an inability to move the instrument at all, being that the instrument was not flexible when turning.A black insulation on the cautery cable was stripped or damaged, and an exposed wire was observed.There was a loss of cautery associated with the broken black cable, and there were signs of thermal damage at the site of breakage, although no arcing was observed during the procedure.Procedure details were provided.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has issued a return material authorization (rma) to have the intuitive device returned.However, isi has not received the permanent cautery spatula instrument involved with the alleged issue to perform failure analysis.Additional information is being gathered to determine the contribution of the device to the customer reported issue.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The permanent cautery spatula instrument was analyzed and found to have a derailed grip cable from its normal position at the distal end.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.The complaint was confirmed by failure analysis.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 derailed or loose at the distal end.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: PERMANENT CAUTERY SPATULA
• 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: 22145934
• Report Number: 2955842-2025-23894
• Device Sequence Number: 8328641
• Product Code: NAY
• UDI-Device Identifier: 00886874111543
• UDI-Public: (01)00886874111543(10)N10170926
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2025

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: 420184-11
• Device Catalogue Number: 420184
• Device Lot Number: N10170926 579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/21/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2017
• 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: Reuse
• 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