MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST SP; MEDIUM-LARGE CLIP APPLIER

Model Number	430005-57
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted benign hysterectomy surgical procedure, the single port (sp) medium-large clip applier instrument was not responding correctly.The surgeon described the issue as the arm was drifting on.No fragment fell into the patient.The user completed the procedure, and no known impact or patient consequence was reported.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the medium-large clip applier instrument was not responding correctly, and the surgeon used the term drifting to describe the incorrect action.The incident did not affect the outcome of the procedure, and the procedure was completed without incident.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the single port (sp) medium-large clip applier instrument to perform failure analysis (fa).Fa was able to confirm and reproduce the customer reported complaint.The instrument was found to have roll input disk broken inside the housing.Other backend components adjacent to the broken inputs show damage which may indicate potential improper reprocessing.Bearing corrosion was observed.This failure likely caused the imprecise motion observed.The input disk component uses ultem or peek material that is insert-molded over a steel pin.The insert molding process creates residual stress in the input disk.These residual stresses can be susceptible to chemical or thermal stresses, which can cause cracks in the ultem or peek material.Under repeated or prolonged chemical or thermal exposure cycles, these cracks can grow into larger cracks and may cause the input disk to break and detach from the instrument.Fa found the secondary failure of imprecise motion to be related to the customer reported 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 an imprecise motion was observed in the roll direction.Additional observation not reported by site: the instrument was found to have corrosion on the bearings.The joggle left/right, yaw, pitch, and joggle up/down input disk bearings has oxidation, characterized by orange discoloration.Corrosion developed along the outer ring on the bearings.
Additional Manufacturer Narrative
Dhr review for the device(s) involved with the reported event has been completed.No non-conformances were identified to be related to this complaint.Common causes of the failure mode broken instrument input disks are attributed to use and incorrect reprocessing conditions.The input disk component uses ultem or polyether ether ketone (peek) material that is insert-molded over a steel pin.The insert molding process creates residual stress in the input disk.These residual stresses can be susceptible to chemical or thermal stresses, which can cause cracks in the ultem or peek material.Under repeated or prolonged chemical or thermal exposure cycles, these cracks can grow into larger cracks and may cause the input disk to break and detach from the instrument.Common cause of the imprecise motion is attributed to the user.Common causes of the failure mode corroded / contaminated instrument bearings include improper cleaning or sterilization techniques used during reprocessing, which may involve prolonged exposure of the instrument to harsh cleaning agents or insufficient flushing.

• Brand Name: ENDOWRIST SP
• Common Device Name: MEDIUM-LARGE CLIP APPLIER
• 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: 21586658
• Report Number: 2955842-2025-07381
• Device Sequence Number: 21049849
• Product Code: NAY
• UDI-Device Identifier: 00886874114292
• UDI-Public: (01)00886874114292(10)U10220317
• 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,Followup
• Report Date (Section B): 02/13/2025

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: 430005-57
• Device Catalogue Number: 430005
• Device Lot Number: U10220317 0030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2025
• Supplement Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2022
• 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