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

Model Number	471172-19
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the maryland bipolar forceps instrument to perform failure analysis (fa).Fa was able to confirm/reproduce the reported complaint.The instrument was found to have thermal damage on the yaw pulley.A visual inspection was completed, and there was no damage to the distal tip.The instrument was placed and driven on an in-house system.The instrument passed the recognition and engagement tests.The instrument grips were manually manipulated, and the instrument passed an electric continuity test on 3 of 3 attempts.The instrument delivered energy without any issues on 3 of 3 attempts.The probable root cause of thermal damage is attributed to carbonized tissue on the grips of this bipolar instrument creating a conductive path during use.Thermal damage can also result due to inadvertent energy application from a monopolar instrument.
Event or Problem Description
It was reported that during central processing, the tip of a maryland bipolar forceps instrument had the coating burnt off.There was no report of patient involvement.Intuitive surgical, inc.(isi) followed up with the initial reporter to obtain additional information: the customer indicated that no arcing was observed during the last procedure, no patient injury occurred.

• 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 ; +1(408)523-2100
• MDR Report Key: 50906721
• Report Number: 2955842-2026-40124
• Device Sequence Number: 9976334
• Product Code: NAY
• UDI-Device Identifier: 00886874119792
• UDI-Public: (01)00886874119792(10)K17260401
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: 471172-19
• Device Catalogue Number: 471172
• Device Lot Number: K17260401 0116
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/16/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2026
• 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