MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; MEGA NEEDLE DRIVER

Model Number	470194-09
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the mega needle driver instrument to perform failure analysis.The instrument was found to have a broken grip at the grip base.A piece approximately 7.42mm x 3.21mm was found to be broken off, confirming that a fragment detached from the instrument.The broken piece was not returned with the instrument.The probable root cause is attributed to damage during use, which may result from applying excess force on the instrument shafts and/or tips during handling, insertion, usage (overloading), or removal.
Event or Problem Description
It was reported that during central processing, the jaws of a mega needle driver instrument were misaligned.There was no report of patient involvement.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: no fragments fell into patient's anatomy.The damage to the instrument occurred outside of a surgical procedure.

• Brand Name: ENDOWRIST
• Common Device Name: MEGA 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 ; 4085232100
• MDR Report Key: 25155498
• Report Number: 2955842-2026-24832
• Device Sequence Number: 9323850
• Product Code: NAY
• UDI-Device Identifier: 00886874112342
• UDI-Public: (01)00886874112342(11)250807(10)K10250807(91)0009
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K150284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/12/2026

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: 470194-09
• Device Catalogue Number: 470194
• Device Lot Number: K10250807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2025
• 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