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

Model Number	430009-62
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has not received the instrument for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received.
Event or Problem Description
It was reported that during a da vinci-assisted hysterectomy surgical procedure, the cadiere forceps instrument was bending in the opposite direction to the surgeon's command.The procedure was completed with no patient harm.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The cadiere forceps instrument housing was removed, and the instrument was found to have a broken roll gear.The instrument was installed on an in-house system and driven.The instrument exhibited unintuitive motion.The motion exhibited by the instrument was precise, and proportional to what was commanded by the master tool manipulators (mtm), however the grip tips moved in the opposite direction.This behavior was observed in the roll direction and presented on qty three out of three installs, indicating a misalignment of the coordinate frames during the engagement sequence.This failure is likely due to the broken roll gear observed.The complaint was confirmed by failure analysis.The probable root cause based on failure analysis may be attributed to damage during use or reprocessing.Damage can result from mechanical impact, such as an accidental drop of the instrument.The probable root cause of unintuitive motion is attributed to the broken roll gear.The probable root cause is attributed to a partially seated instrument and subsequent disengagement.Motion issues are a result of the sterile adapter disk pegs only being partially seated during the instrument engagement routine on the instrument arm.Due to this partial engagement, the input disk controlling instrument grip could disengage sometime after the engagement routine has registered a successful grip engagement and before the instrument is inserted through the cannula.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
The following probable root cause statement was submitted in error in the previous report and should be removed: the probable root cause is attributed to a partially seated instrument and subsequent disengagement.Motion issues are a result of the sterile adapter disk pegs only being partially seated during the instrument engagement routine on the instrument arm.Due to this partial engagement, the input disk controlling instrument grip could disengage sometime after the engagement routine has registered a successful grip engagement and before the instrument is inserted through the cannula.
Event or Problem Description
Refer to h11 for follow-up information.

• 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: 22377507
• Report Number: 2955842-2025-28427
• Device Sequence Number: 18135708
• Product Code: NAY
• UDI-Device Identifier: 00886874115213
• UDI-Public: (01)00886874115213(11)240516(10)K10240516(91)0004
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K182371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/10/2025

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: 430009-62
• Device Catalogue Number: 430009
• Device Lot Number: K10240516 0031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/10/2025
• Supplement Date Received by Manufacturer: 07/25/2025; 09/08/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 08/20/2025; 09/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2024
• 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: Female