MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; LONG TIP FORCEPS

Model Number	471048-09
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The long tip forceps instrument was analyzed and found to have a broken grip at the grip base.A piece approximately 0.130¿ x 0.668¿ was found to be broken off, confirming that a fragment detached from the instrument.The part was not returned with the instrument.The complaint was confirmed by failure analysis.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 long tip forceps instrument was broken.No known impact or patient consequence was reported.

• Brand Name: ENDOWRIST
• Common Device Name: LONG TIP 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: 23985289
• Report Number: 2955842-2026-00407
• Device Sequence Number: 14596934
• Product Code: NAY
• UDI-Device Identifier: 00886874121467
• UDI-Public: (01)00886874121467(11)241114(10)K10241114(91)0005
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K214095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/06/2026

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: 471048-09
• Device Catalogue Number: 471048
• Device Lot Number: K10241114 0063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2024
• 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: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Unknown