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

Model Number	430009-57
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The cadiere forceps instrument was analyzed and found to have a broken snake wrist cable at the distal joggle joint.The cable was fully broken.There was no evidence of discoloration, corrosion, or contamination on the cables to indicate a reprocessing-induced issue.The components surrounding the broken cable did not exhibit abnormal sharp edges or damage that would have contributed to the cable breaking.The instrument was installed on an in-house system and driven.The instrument exhibited unintuitive motion.In an attempt to roll the grip tips, while keeping the rest of the instrument stationary, the distal end rotates unexpectedly.The distal end results in a wider swing than is intended.This is likely due to the broken snake wrist cable observed.The complaint was confirmed by failure analysis, which indicates that the device may have contributed to the customer reported issue.Failure analysis confirmed the initial findings.The instrument does appear to exhibit unintuitive motion.With the instrument's wrist bent and the grips open, the master tool manipulator (mtm) was rotated back and forth between the range of motion for the rotation axis.At the end of the range of motion for rotation, the grips moved as expected, spinning and rotating while staying in place.However, around midway between the ends of the range of rotational motion, it was observed that the grips would stop spinning as expected and would unintuitively swing in a circle.The probable root cause of cable breakage, whether partial or full, is attributed to reduction in ultimate strength of the material, which may be the result of damage to the cable through external collisions, during use, or during reprocessing.
Event or Problem Description
It was reported that during a da vinci-assisted radical extraperitoneal prostatectomy with lymphadenectomy surgical procedure, the cadiere forceps instrument had a loose cable and would not rotate at the wrist.The customer replaced the cadiere forceps instrument with a back-up instrument of the same kind and completed the procedure with no reported injury.

• Brand Name: ENDOWRIST SP
• Common Device Name: CADIERE 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: 22015154
• Report Number: 2955842-2025-20265
• Device Sequence Number: 21019735
• Product Code: NAY
• UDI-Device Identifier: 00886874115213
• UDI-Public: (01)00886874115213(10)U10240201
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 02/10/2025

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: 430009-57
• Device Catalogue Number: 430009
• Device Lot Number: U10240201 0002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2025
• Initial Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2024
• 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: Unknown
• 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: Male