MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; BLACK DIAMOND MICRO FORCEPS

Model Number	470033-09
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has not received the instrument for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received.
Event or Problem Description
It was reported that during a da vinci-assisted radical cystectomy with neobladder surgical procedure, the black diamond micro forceps instrument did not open or close.The tip opened itself.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the issue occurred when the surgeon¿s head inside the surgeon console¿s high resolution stereo viewer and was attempting to manipulate the instruments.The surgeon was trying to open the jaws.There were no patterns identified.There was no injury to the patient.There were no external collisions.The device was inspected prior to use.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has received the black diamond micro forceps instrument associated with this complaint and completed investigations.The instrument was found to have both bent grips causing misalignment of the grips.There was a 0.61 mm offset at the tips.The grips do not show cracking damage.The components adjacent to this bent grip do not show damage.The complaint was confirmed by failure analysis.The probable root cause of severely bent grips is attributed to damage either during use or reprocessing, as severe misalignment of grip tips can be due to accidental drops, incorrect instrument tray or sink sizes for reprocessing, or overloading the tips.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: ENDOWRIST
• Common Device Name: BLACK DIAMOND MICRO 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: 23965236
• Report Number: 2955842-2025-49732
• Device Sequence Number: 4888127
• Product Code: NAY
• UDI-Device Identifier: 00886874112229
• UDI-Public: (01)00886874112229(10)N10190206
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K131861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/15/2026

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: 470033-09
• Device Catalogue Number: 470033
• Device Lot Number: N10190206 0008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/09/2025
• Supplement Date Received by Manufacturer: 01/15/2026; 03/23/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 02/05/2026; 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2019
• 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