MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST SP; FENESTRATED BIPOLAR FORCEPS

Model Number	430011-62
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the da vinci product to perform failure analysis.The fenestrated bipolar forceps instrument was analyzed and found to have a broken constraint cable at the wrist disc.The cable was fully broken approximately 102.92mm from the distal tip.There was not evidence of discoloration or corrosion/contamination on the cables to indicate a reprocessing induced issue.Visual inspection confirmed there were no dislodged crimps observed.The components surrounding the broken cable did not exhibit abnormal sharp edges or damage that would have contributed to the cable breaking.Common causes of broken - distal instrument snake wrist cables, whether partial or full, may be attributed to reduction in ultimate strength of the material, due to damage to the cable through external collisions, during use, or during reprocessing.
Event or Problem Description
It was reported that the customer experienced an issue with an intuitive product.The customer reported event has no report of patient injury.

• Brand Name: ENDOWRIST SP
• Common Device Name: FENESTRATED BIPOLAR FORCEPS
• 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: 24946730
• Report Number: 2955842-2026-22408
• Device Sequence Number: 5406637
• Product Code: NAY
• UDI-Device Identifier: 00886874114339
• UDI-Public: (01)00886874114339(10)K10250327
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K182371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/21/2026

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: 430011-62
• Device Catalogue Number: 430011
• Device Lot Number: K10250327 0020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2025
• 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 Sex: Unknown