MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST SP; CADIERE FORCEPS

Model Number	430009-52
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The 6mm cadiere forceps instrument was analyzed and found to have roll input disk broken into pieces an a grip input broken inside the housing.As a result of the fully broken inputs, functional testing for motion related issues could not performed.A broken pieces of the roll input disk was found inside the housing with a measurement of 0.36mm x 0.21mm and 0.17mm x 0.28 mm was found.Due to the broken roll input, the instrument failed imprecise motion on roll direction of the instrument while the broken grip input didn't cause any issue regarding opening ang closing the grip.If the input disk is fully broken, then the instrument can fail to engage.The issue is immediately detectable by the surgeon due to loss of instrument functionality.Additional observation related to the customer complaint: the instrument was installed on an in-house system and driven.Instrument exhibited imprecise motion in the roll direction.The grip tips moved in the direction commanded, however a lag or delay in the motion was observed due to the broken roll input.Additional observation(s) not reported by site: the instrument was found to have clamping pulley residue.The instrument's housing was removed and upon inspection, the instrument w found to have an excessive amount of dried, white residue on the clamping pulleys for inputs joggle left/right, yaw, pitch, and joggle up/down, located inside the backend of the instrument.The instrument was found to have corroded bearings.The instrument was visually inspected through camera head inspection using a housing removal tool to remove the housing cover.Upon inspection, the instrument was found to have corrosions on bearings for grip, pitch, yaw, and joggle inside the housing.The bearing ball outside the housing also appears to be corroded.The complaint was confirmed by failure analysis.The probable root cause is attributed to use and reprocessing conditions.The input disk can be susceptible to chemical or thermal stresses, which can result in the appearance of cracks.Under repeated or prolonged chemical or thermal exposure cycles, these cracks can propagate into larger cracks, and may cause the input disk to break and separate from the instrument.
Event or Problem Description
It was reported that during a da vinci-assisted thymectomy surgical procedure, the 6mm cadiere forceps instrument worked in the opposite direction as intended.Left was right and up was down.The surgical team tried to reseat the instrument and drape repeatedly.The procedure was completed, and no injuries were reported.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: there was no injury to the patient as a result of the event.There was no instrument-to-instrument or system arm-to-arm interference, and no external collisions occurred with equipment or staff.No photographic images or video recordings are available for review.

• Brand Name: ENDOWRIST SP
• Common Device Name: CADIERE FORCEPS
• 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: 24793676
• Report Number: 2955842-2026-20342
• Device Sequence Number: 12923181
• Product Code: NAY
• UDI-Device Identifier: 00886874115213
• UDI-Public: (01)00886874115213(10)S11210419
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K182371
• 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): 04/06/2026

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: 430009-52
• Device Catalogue Number: 430009
• Device Lot Number: S11210419 0004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2021
• 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