MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST SP; MONOPOLAR CAUTERY INSTRUMENT

Model Number	430007-55
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The monopolar cautery instrument was analyzed and found to have missing electrical contacts due to the broken tube adapter.The missing electrical contacts measure 5 mm and were not returned.The instrument was found to have a detached fragment.The detached fragment was from the broken instrument tube adapter and was not returned.The detached fragment measures approximately 3.93 mm x 5.71 mm in size.The instrument was found to have one or more of the housing snaps broken.The broken piece was returned, measuring roughly 2.75 mm x 7.20mm in size.The housing snaps are located within the proximal end of the instrument and secure the housing to the instrument chassis.Four tabs appear to be broken as well and detached from the housing.The complaint was confirmed by failure analysis.The probable root cause of a damaged tube adapter is attributed to either tip accessory installation issues or damage during use.The probable root cause is attributed to damage during use or reprocessing.Damage can result from mechanical impact, such as an accidental drop of the instrument.Improper cleaning during reprocessing, such as prolonged exposure of the instrument to harsh cleaning agents, can lead to cracking and subsequent breakage.
Event or Problem Description
It was reported that during central processing, the monopolar curved scissors instrument had a broken tip.No known impact or patient consequence was reported.

• Brand Name: ENDOWRIST SP
• Common Device Name: MONOPOLAR CAUTERY INSTRUMENT
• 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: 24786945
• Report Number: 2955842-2026-20660
• Device Sequence Number: 9904375
• Product Code: NAY
• UDI-Device Identifier: 00886874114315
• UDI-Public: (01)00886874114315(10)S10190315
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K182371
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 04/05/2026

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: 430007-55
• Device Catalogue Number: 430007
• Device Lot Number: S10190315 0009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 04/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2019
• 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