MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; POTTS SCISSORS

Model Number	470001-12
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) requested the da vinci product to perform failure analysis.However, as of the date of this report, the instrument has not been received.The probable root cause cannot be determined without the failure analysis of the instrument.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the potts scissor instrument had a "blade gap" when it was installed on the robotic arm.The customer reported event has no report of patient injury.
Additional Manufacturer Narrative
Intuitive surgical (is) obtained the following additional information regarding this event: the issue caused a delay of less than 15 minutes.
Event or Problem Description
Refer to h11 for follow-up information.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis, and the complaint was confirmed.The potts scissors instrument was analyzed and found to have one blade bent at the tip.Bend point is located approximately 0.2 mm from the tip of the blade.Components adjacent to this bent blade do not show damage.The probable root cause of bent blades is attributed to damage during use, as moderate misalignment of tips may result from attempting to grasp either hard tissue/objects or inadvertent collisions with other instruments.Applying excessive force on the instrument tips during handling, insertion, usage (overloading), or removal can also cause bending.

• Brand Name: ENDOWRIST
• Common Device Name: POTTS SCISSORS
• 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: 24948738
• Report Number: 2955842-2026-22464
• Device Sequence Number: 17494477
• Product Code: NAY
• UDI-Device Identifier: 00886874112120
• UDI-Public: (01)00886874112120(11)251030(10)K10251030
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K131861
• 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,Followup,Followup
• Report Date (Section B): 05/13/2026

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: 470001-12
• Device Catalogue Number: 470001
• Device Lot Number: K10251030 0030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/08/2026
• Supplement Date Received by Manufacturer: 04/13/2026; 05/12/2026
• Initial Report FDA Received Date: 04/22/2026
• Supplement Report FDA Received Date: 04/23/2026; 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2025
• 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: 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 Age: 20 MO
• Patient Sex: Male
• Patient Weight: 13 KG