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

Model Number	471172-19
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted radical prostatectomy without lymphadenectomy procedure, the maryland bipolar forceps instrument broke due to a collision with prograsp forceps.A fragment from the maryland bipolar fell into the patient and was retrieved during the same procedure.The procedure was completed.Intuitive surgical, inc.(isi) made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.
Additional Manufacturer Narrative
The maryland bipolar forceps instrument has not been received for failure analysis evaluation.A photo was provided confirming the instrument lot information.

• 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: 50883699
• Report Number: 2955842-2026-39859
• Device Sequence Number: 18807555
• Product Code: NAY
• UDI-Device Identifier: 00886874119792
• UDI-Public: (01)00886874119792(11)250702(10)K13250702(91)0002
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K214095
• 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
• Report Date (Section B): 09/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Model Number: 471172-19
• Device Catalogue Number: 471172
• Device Lot Number: K13250702 0181
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/02/2025
• 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: Reuse
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown