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

Model Number	430010-62
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the 6mm maryland bipolar forceps instrument to perform failure analysis.The instrument was analyzed and it was found to have a bent main tube.The bending damage was located at the proximal end of the main tube.As a result, the instrument did not perform during roll function as expected.The instrument, however, did move correctly in all directions.The probable root cause of unintuitive motion experienced by customer cannot be determined from the information provided.The probable root cause of bent main tube is attributed to damage during use, which may result from an accidental drop of the instrument or inadvertent collisions with other instruments.Applying excessive force on the instrument shafts and/or tips during handling, insertion, usage (overloading), or removal can also cause bending.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the 6mm maryland bipolar forceps instrument did not work as expected.The procedure was completed with no reported injury.Intuitive surgical inc., (isi) followed up with the initial reporter and obtained the following additional information: the conductor wire of instrument was not damaged on the wrist.No other physical damage was observed.No material was missing or detached from the portion of the device that enters the patient¿s body.There was no allegation of an unclamping failure while the instrument was gripping tissue.The instrument did not move/function as intended.The instrument was not moving intuitively.

• Brand Name: ENDOWRIST SP
• 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: 23822326
• Report Number: 2955842-2025-47082
• Device Sequence Number: 9386409
• Product Code: NAY
• UDI-Device Identifier: 00886874114322
• UDI-Public: (01)00886874114322(11)250605(10)K10250605
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/16/2025

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: 430010-62
• Device Catalogue Number: 430010
• Device Lot Number: K10250605 0025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/05/2025
• 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