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

Model Number	470001-09
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The instrument involved in this complaint has not been received and/or tested by failure analysis as of the date of this report.If the product is received and evaluated, a supplemental mdr will be submitted.
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.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the da vinci product to perform failure analysis.The pott scissors instrument was analyzed and found to have both blade(s) bent at the tip.Bend point is located approximately 0.91mm from the tip of the blade.The blades are able to fully close as a result of the bending.Cut performance is not negatively impacted due to the bending.Common causes of the failure mode bent instrument blades are 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.Correction to section d: primary product batch/lot number was updated to k10230720 0010.
Event or Problem Description
Refer to h11 for follow-up information.

• 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: 23611110
• Report Number: 2955842-2025-45771
• Device Sequence Number: 13189779
• Product Code: NAY
• UDI-Device Identifier: 00886874112120
• UDI-Public: (01)00886874112120(11)230720(10)K10230720
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other,Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2025

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: 0010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/02/2025
• Supplement Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2023
• 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: ISIFA2024-09-C
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Unknown