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

Model Number	430152-01
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted radical transvesical prostatectomy surgical procedure, the 6mm maryland bipolar forceps instrument tip was not articulating well.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 issue was related to the movement of the instrument and occurred while the surgeon¿s head was inside the high resolution stereo viewer, as the surgeon was attempting to manipulate instruments from the surgeon console.The issue was resolved by replacing the instrument with a new one, but the drape is not available for return.There was no injury to the patient, and the instrument has already been returned for evaluation.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has not received the da vinci product with an alleged issue to perform failure analysis.A follow-up mdr will be submitted if the product is returned and evaluated and/or if additional information is received.
Additional Manufacturer Narrative
Intuitive surgical inc.(isi) received the 6mm maryland bipolar forceps instrument for failure analysis investigation.The instrument was analyzed and have a broken housing snap tab.For clarification, the broken housing snap tab was found lodged between the roll idler gears, preventing the roll input mechanism from functioning properly.Once the broken snap tab was removed, each input disk was manually articulated and responded accordingly with no issues.The broken piece was measuring approximately 5.1m x 8.8mm and was returned with the instrument.The housing snaps are located within the proximal end of the instrument and secure the housing to the instrument chassis visual inspection was performed and there was no external damage to the snake wrist and shaft.Additional observation(s) not reported by site: the instrument was found to have residue.Visual inspection was preformed and white residue was observed on four of the clamping pulleys, located inside the backend of the instrument.The instrument was found to have multiple corroded bearings.The housing was removed for inspection, and orange discoloration was observed on tear bearings near the clamping pulleys, input disk and grip input, which indicated corrosion.The complaint was confirmed by failure analysis.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
Refer to h11 for follow-up information.

• 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: 24811353
• Report Number: 2955842-2026-20339
• Device Sequence Number: 18530835
• Product Code: NAY
• UDI-Device Identifier: 00886874123461
• UDI-Public: (01)00886874123461(10)H10250731
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K241814
• 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,Followup
• Report Date (Section B): 05/18/2026

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: 430152-01
• Device Catalogue Number: 430152
• Device Lot Number: H10250731 0016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/13/2026
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2025
• 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: Male