MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; CLIP APPLIER, SMALL, HORIZON

Model Number	470401-07
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a frayed cable with a da vinci product.The customer reported event has no report of patient injury.
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.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the da vinci product to perform failure analysis.The horizon small clip applier instrument was analyzed and found to have hairline cracks on input axis 6 and 7 axis.Both tall input disks is cracked.Additional observation(s) not reported by site: the instrument was found to have a loose grip cable at the two tall inputs inside the housing at proximal end.Further inspection found cracked, input disks that could have contributed to the cable loosening.Common causes of the failure mode cracked instrument input disks are attributed to use and incorrect reprocessing conditions.The input disk component uses ultem or peek material that is insert-molded over a steel pin.The insert molding process creates residual stress in the plastic portion of the input disk.These residual stresses can be susceptible to chemical or thermal stresses, which can result in the appearance of cracks in the ultem or peek material.Under repeated or prolonged chemical or thermal exposure cycles, these cracks can propagate into larger cracks and may cause the input disk to break and separate from the instrument.The probable root cause is attributed to a loss of cable tension which may have resulted from a stretched cable due to an unknown cause.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: ENDOWRIST
• Common Device Name: CLIP APPLIER, SMALL, HORIZON
• 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: 24654589
• Report Number: 2955842-2026-17007
• Device Sequence Number: 17664304
• Product Code: NAY
• UDI-Device Identifier: 00886874112670
• UDI-Public: (01)00886874112670(11)221014(10)K11221016
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K150837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification,Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2026

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: 470401-07
• Device Catalogue Number: 470401
• Device Lot Number: K11221016 0025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/04/2026
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2022
• 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: ISIFA2022-05-C, ISIFA202
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES.
• Patient Sex: Unknown