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

Model Number	470401-07
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2026
Type of Reportable Event	Malfunction
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
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.Review of the provided image is consistent with a broken cable and not being recognized.Root cause of the failure mode cannot be confirmed without the returned device.

• 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: 25009305
• Report Number: 2955842-2026-23030
• Device Sequence Number: 9300823
• Product Code: NAY
• UDI-Device Identifier: 00886874112670
• UDI-Public: (01)00886874112670(11)241107(10)K10241107
• Combination Product (Y/N): N
• Initial Reporter Country: QA
• PMA/510(K) Number: K150837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification,Other
• Type of Report: Initial
• Report Date (Section B): 04/27/2026

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: K10241107 0204
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/07/2024
• 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: ISIFA2022-05-C, ISIFA202
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Unknown