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

Model Number	430009-57
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The cadiere forceps instrument was analyzed and removed to perform inspection on the back-end components.A visual inspection found that the roll input disk was broken.The broken input disk is causing the instrument to move imprecisely when driven on the system.The instrument was installed on an in-house system and driven and 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.The imprecise motion was caused by the broken roll input disk.The complaint was confirmed by failure analysis.The probable root cause is attributed to use and reprocessing conditions.
Event or Problem Description
It was reported that during a da vinci-assisted nipple sparing mastectomy surgical procedure, the cadiere forceps instrument was not moving as expected.There were no delays or interruptions with the procedure.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 issue occurred with the surgeon¿s head inside the surgeon console¿s high resolution stereo viewer.The issue occurred while the surgeon was attempting to manipulate instruments from the surgeon console.The movements of the surgeon did not scale appropriately to the instrument.The distance was more and opposite left/right.Twisting clockwise and counter were correct.The timing of instrument movement was appropriate.There was no instrument-to-instrument or system arm-to-arm interference.The customer pulled back all instruments and camera to the snow globe and just tried using the cadiere in port 2.The issue was not resolved.The instrument was removed, and the port was not used after that.There was no injury to the patient.
Additional Manufacturer Narrative
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: 21955846
• Report Number: 2955842-2025-17336
• Device Sequence Number: 9252958
• Product Code: NAY
• UDI-Device Identifier: 00886874115213
• UDI-Public: (01)00886874115213(11)221229(10)U11221229
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2025

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: 430009-57
• Device Catalogue Number: 430009
• Device Lot Number: U11221229 0010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/08/2025
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 05/04/2025
• Supplement Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/29/2022
• 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 Age: 53 YR
• Patient Sex: Female
• Patient Weight: 62 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White