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

Model Number	480299-08
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted procedure, the tip of the suction irrigator instrument broke off, and a fragment fell into the patient's anatomy.The fragment was successfully retrieved during the same procedure.A backup instrument was used to complete the procedure, and no patient injury was reported.No additional procedure was required.
Additional Manufacturer Narrative
Intuitive surgical inc.(isi), has not received the suction irrigator instrument to perform failure analysis.

• 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 ; +1(408)523-2100
• MDR Report Key: 50900570
• Report Number: 2955842-2026-39965
• Device Sequence Number: 5903781
• Product Code: NAY
• UDI-Device Identifier: 10886874114817
• UDI-Public: (01)10886874114817(10)K14260307
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K162973
• 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
• Report Date (Section B): 09/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Model Number: 480299-08
• Device Catalogue Number: 480299
• Device Lot Number: K14260307
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/05/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown