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

Model Number	480299-06
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during da vinci-assisted surgical procedure, the suction tip was bent and could not be removed from the cannula.Or staff pulled out the instrument and cannula together, and the instrument was broken using the foot to separate it from the cannula.The procedure was completed with no reported injury.Intuitive followed up with the initial reporter and obtained the following additional information: the incident involved a breakage of the instrument shaft near the wrist while separating from the cannula.The broken part was completely detached from the rest of the instrument.However, no fragment fell into the patient because the entire instrument and cannula were removed from the patient before separation.There was no collision with other instruments or hard materials during the procedure, and no photographic images or video recordings are available for review by intuitive surgical, inc.(isi).
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did not receive the da vinci product with an alleged issue to perform failure analysis.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.Failure analysis investigations did replicate and confirm the customer complaint "the suction tip was bent and could not be remove from the cannula.Or staff pulled out the instrument and cannula together, and the instrument was broken using the foot to separate it from the cannula".The instrument was returned by the customer in a severely damaged condition.Due to the damage, the failure analysis team is unable to perform test related to the customer's complaint.A section beyond the proximal end was fractured and a piece (approximately 7.66 mm x 4.98 mm) was not returned.The main tube was fractured without material missing.The cable was fully severed, with no signs of discoloration or corrosion.The probable root cause is attributed to damage during use, which may result from applying excess force on the instrument grip tips during handling, insertion, usage (overloading), or removal.This issue can be resolved by using an alternate instrument to complete the procedure.
Event or Problem Description
Refer to h11 for follow-up information.

• 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: 24478465
• Report Number: 2955842-2026-14656
• Device Sequence Number: 13317268
• Product Code: NAY
• UDI-Device Identifier: 10886874114817
• UDI-Public: (01)10886874114817(10)K10250605
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K162973
• 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
• Report Date (Section B): 05/04/2026

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: 480299-06
• Device Catalogue Number: 480299
• Device Lot Number: K10250605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2026
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2025
• 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: Female