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

Model Number	470001-09
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The 8mm potts scissors instrument has been returned and evaluated by the failure analysis (fa) team.The instrument was found to have one blade bent at the tip.The bend point is located approximately 1.98mm from the tip of the blade.The blades cannot fully close as a result of the bending.Cut performance is negatively impacted due to the bending.Additionally, the instrument was found to have one blade broken at the tip.A piece approximately 0.41mm x 0.82mm was found to be broken off, confirming that a fragment detached from the instrument.The broken piece was not returned.Components adjacent to this broken blade do not show damage.The complaint was confirmed by failure analysis.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.
Event or Problem Description
It was reported that during central processing, the 8mm potts scissors instrument tip was broken and bent.There was no report of patient involvement.

• 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: 25178114
• Report Number: 2955842-2026-25134
• Device Sequence Number: 10755465
• Product Code: NAY
• UDI-Device Identifier: 00886874112120
• UDI-Public: (01)00886874112120(11)230601(10)K10230601(91)0003
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K131861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/14/2026

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: 470001-09
• Device Catalogue Number: 470001
• Device Lot Number: K10230601 0045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2023
• 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 Sex: Unknown