MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; MARYLAND BIPOLAR FORCEPS

Model Number	470172-16
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the da vinci product with an alleged issue to perform failure analysis.The maryland bipolar forceps instrument has been returned and evaluated by the failure analysis (fa) team.The instrument was found to have a broken tube at the proximal clevis.A broken piece, measuring roughly 0.315" x 0.091" in size.Thermal damage was not observed.Additionally, a component adjacent to the instrument was found to have a dislodged proximal clevis.The probable root cause of a broken tube extension is attributed to damage during use, which may result from inadvertent collisions with other instruments, instruments driven outside the field of view, or using the mcs instrument to retract anatomy.The mcs instrument has an over molded design at the tube extension location, which can allow cleaning chemicals to seep into the main tube/extension tube interface that enable prolonged chemical exposure and hence accelerate material degradation.Adequate rinsing during the cleaning process is critical to ensure all chemicals have been removed from this over molded area.Applying excessive force on the mcs instrument tips during handling, insertion, usage (overloading), or removal can cause breakage.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the maryland bipolar forceps instrument was not identified.The procedure was completed with no reported injury.

• Brand Name: ENDOWRIST
• Common Device Name: MARYLAND BIPOLAR 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: 25024519
• Report Number: 2955842-2026-23234
• Device Sequence Number: 10126798
• Product Code: NAY
• UDI-Device Identifier: 00886874112281
• UDI-Public: (01)00886874112281(11)210624(10)N10210628
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K131861
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 04/28/2026

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: 470172-16
• Device Catalogue Number: 470172
• Device Lot Number: N10210628 0058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2021
• 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