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

Model Number	430011-57
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted radical extraperitoneal prostatectomy without lymphadenectomy procedure, the tip of the fenestrated bipolar instrument was observed to be broken.A fragment fell inside the patient but was retrieved during the same surgical procedure which was completed robotically.The initial reporter indicated that the instrument broke while the or staff was holding an ultrasound device.No additional surgical procedure was required and no x-rays were performed due to the event.
Additional Manufacturer Narrative
The fenestrated bipolar instrument was received, and failure analysis found the instrument to have a broken molded insulator on the lower jaw.The broken piece measures approximately 1.23mm x 6.10mm, confirming that a fragment detached from the instrument and was not returned with the instrument.The grip base for the grip with the cracked molded insulator does not appear to be bent.Additionally, the instrument was found to have a detached fragment.The detached fragment broke off from the instrument's molded insulator.The broken piece was not returned.The instrument was found to have a detached intact jaw.The jaw became detached as a result of the break in the molded insulator.The detached jaw was returned with the instrument.The instrument was found to have a broken conductor wire at the distal end.The conductor wire broke as a result of the break in the molded insulator.No thermal damage was found on the instrument.

• Brand Name: ENDOWRIST SP
• Common Device Name: FENESTRATED 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: 24190297
• Report Number: 2955842-2026-02220
• Device Sequence Number: 18145014
• Product Code: NAY
• UDI-Device Identifier: 00886874114339
• UDI-Public: (01)00886874114339(10)K10240118
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/27/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 430011-57
• Device Catalogue Number: 430011
• Device Lot Number: K10240118 0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/31/2025
• Initial Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2024
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown