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	04/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did not receive the da vinci product with an alleged issue to perform failure analysis.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, single-port (sp) cadiere forceps (cf) instrument moved in the opposite direction of the surgeon¿s control.The customer continued the procedure without the cf instrument.There was no patient injury.Isi followed up with the initial reporter and obtained the following additional information: the issue occurred on (b)(6) 2025.The issue was resolved by using a backup instrument.There was no fragment falling inside the patient.There was no patient injury.
Additional Manufacturer Narrative
The procedure was a malignant hysterectomy.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
The cadiere forceps instrument was analyzed and the housing was removed, and the instrument was found to have a broken roll gear.This failure likely caused the unintuitive motion observed.The common cause of this failure is attributed to the user.Additionally, 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 manipulator (mtm); however, the grip tips moved in the opposite direction.This behavior was observed in the roll direction and presented on all 3 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, which indicates that the device may have contributed to the customer-reported issue.The probable root cause is attributed to damage during use, which may result from an accidental drop of the instrument or inadvertent collisions with other instruments or hard surfaces.
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: 22029568
• Report Number: 2955842-2025-20464
• Device Sequence Number: 8503542
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/23/2025

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 0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/23/2025
• Supplement Date Received by Manufacturer: 05/21/2025; 06/17/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 06/11/2025; 07/10/2025
• 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