MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC EndoWrist; LARGE SUTURE CUT NEEDLE DRIVER

Model Number	471296-08
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2026
Type of Reportable Event	Malfunction

• Brand Name: EndoWrist
• Common Device Name: LARGE SUTURE CUT NEEDLE DRIVER
• 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 ; +1(408)523-2100
• MDR Report Key: 50508864
• Report Number: 2955842-2026-37249
• Device Sequence Number: 18485514
• Product Code: NAY
• UDI-Device Identifier: 00886874121504
• UDI-Public: (01)00886874121504(11)240627(10)K10240627(91)0006
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K214095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification,Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2026

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: 471296-08
• Device Catalogue Number: 471296
• Device Lot Number: K10240627 0310
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/19/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/03/2026
• Supplement Date Received by Manufacturer: 09/14/2026
• Initial Report FDA Received Date: 08/28/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2024
• 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: 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
• Patient Sex: Unknown