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

Model Number	430011-62
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An intuitive surgical, inc.(isi) product has not been received for failure analysis evaluation.
Event or Problem Description
It was reported that during a da vinci-assisted myomectomy procedure, the tip of the fenestrated bipolar forceps (fbf) instrument broke and a fragment fell inside the patient.The event occurred while the surgeon was performing dissection.The fragment was successfully retrieved by the surgeon during the same surgical procedure.The surgeon confirmed that all fragments were removed.No additional surgical procedure, such as laparoscopy or open surgery, was required, and no post-operative imaging tests were performed to check for remaining fragments.The procedure was completed robotically using a backup instrument of the same type.There was no injury to the patient, and the patient has not returned to the hospital for any post-surgical complications related to retaining a foreign object.
Additional Manufacturer Narrative
Updated fields: d9, h2, h3, h6, and h11.Intuitive surgical, inc.(isi) received the fenestrated bipolar forceps instrument an alleged issue to perform failure analysis.The instrument was found to have a broken molded insulator on the upper jaw.Two broken pieces measuring approximately 1.60mm x 8.72mm and 2.19mm x 3.57mm in size were identified, confirming that a fragment detached from the instrument and was returned with the instrument.The grip base for the grip with the cracked molded insulator does not appear to be bent.The upper jaw is still attached to the instrument due to the bipolar conductor cable holding it intact.The housing was removed for inspection and found no damage.The inputs were manually articulated, and the roll, joggle, pitch and yaw went to the right directions.Additional observation related to the customer complaint was that the instrument was found to have detached fragments from the broken molded insulator.
Event or Problem Description
Refer to h11 for follow-up information.

• 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: 23823972
• Report Number: 2955842-2025-47369
• Device Sequence Number: 21323107
• Product Code: NAY
• UDI-Device Identifier: 00886874114339
• UDI-Public: (01)00886874114339(10)K10250327
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K182371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2026

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: 430011-62
• Device Catalogue Number: 430011
• Device Lot Number: K10250327 0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/27/2025
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2025
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown