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

Model Number	470207-13
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a da vinci-assisted radical prostatectomy without lymphadenectomy procedure, the wire on a tenaculum forceps instrument completely snapped during the procedure.It is unknown whether any wire fragment detached and was retained in the patient.An x-ray was taken to assess for any retained foreign body.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 tenaculum forceps instrument has been received, however failure analysis has not been completed at this time.

• Brand Name: EndoWrist
• Common Device Name: TENACULUM 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: 50852993
• Report Number: 2955842-2026-39587
• Device Sequence Number: 10026358
• Product Code: NAY
• UDI-Device Identifier: 00886874112366
• UDI-Public: (01)00886874112366(11)250814(10)K10250814
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K131861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Model Number: 470207-13
• Device Catalogue Number: 470207
• Device Lot Number: K10250814 0239
• 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: 08/28/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2025
• 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