MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; SUCTION IRRIGATOR

Model Number	480299-08
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the da vinci product to perform failure analysis.The suction irrigator instrument was analyzed and found to have a broken main tube approximately.085" from the distal tip.No material was found missing.Components adjacent to this broken main tube do show damage.The snake wrist is dislodged, the inner lumen is broken, and snake wrist cable is broken.Additional observations related to customer reported complaint: the instrument was found to have a dislodged snake wrist at the wrist disk end cap, which caused the wrist disks to misalign.There were no missing pieces, and damage was observed to the snake wrist cables.Wrist assembly is not straight and did advance through a cannula.Other components adjacent to the dislodged snake wrist do show damage which may indicate potential mishandling and misuse.The main tube is broken, the inner lumen is broken, and snake wrist cable is broken.The instrument was found to have a broken snake wrist cable at the distal end.The cable was fully broken.There was no evidence of discoloration or corrosion/contamination on the cables to indicate a reprocessing induced issue.The components surrounding the broken cable did exhibit damage that would have contributed to the cable breaking.The main tube is broken, the inner lumen is broken, and snake wrist is dislodged.The instrument was found to have a broken inner lumen at the distal end.Common causes of the failure mode broken instrument main tube are attributed to damage during use, which may result from an accidental drop of the instrument or inadvertent collisions with other instruments.Excessive side loading on the instrument can also cause the main tube wall to collapse inwards causing it to crack and subsequently break.Common causes of the failure mode dislodged instrument snake wrist are attributed to use conditions.Common causes of broken - distal instrument snake wrist cable whether partial or full, are commonly attributed to damage to the cable through external collisions, during transport/storage, during use, or during reprocessing.The missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for section d4 is not applicable.Field d6 is blank because the product is not implantable.Information for the blank fields in section e1 is not available.Field e4 is blank because it is unknown if the initial reporter submitted a report to the fda.Fields g5 and g7 are not applicable.
Event or Problem Description
It was reported that there was a broken cable with a da vinci product.The customer reported event has no report of patient injury.

• Brand Name: ENDOWRIST
• Common Device Name: SUCTION IRRIGATOR
• 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: 25210594
• Report Number: 2955842-2026-25484
• Device Sequence Number: 10369385
• Product Code: NAY
• UDI-Device Identifier: 10886874114817
• UDI-Public: (01)10886874114817(10)K13250919
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K162973
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/18/2026

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: 480299-08
• Device Catalogue Number: 480299
• Device Lot Number: K13250919 0049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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