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

Model Number	430151-02
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2025
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 ovarian cystectomy procedure, the tip of the fenestrated bipolar forceps (fbf) instrument broke and a fragment fell inside the patient.The event occurred during instrument removal.The fragment(s) wererretrieved during the same surgical procedure by irrigation and suctioning.They were unable to confirm that all fragments were retrieved.The procedure was completed robotically using backup fbf instrument.
Additional Manufacturer Narrative
The fenestrated bipolar forceps instrument was received, and failure analysis found the instrument to have a broken molded insulator on the upper jaw.The broken molded insulator likely caused the grip tip to be fully detached.The broken piece was not returned with the instrument.The grip base for the grip with the cracked molded insulator did not appear to be bent.Visual inspection was performed and found no external damage to the housing or main tube.The input disks were manually articulated with no issues.The grip knob was able to rotate, allowing the grips to open/close without any issues.Additionally, the instrument was found to have a detached fragment.Fragments were not returned and were likely caused by the broken over molded insulator.The entire upper grip tip was detached.
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: 23811542
• Report Number: 2955842-2025-47370
• Device Sequence Number: 9333707
• Product Code: NAY
• UDI-Device Identifier: 00886874123447
• UDI-Public: (01)00886874123447(11)250515(10)K10250515
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K241814
• 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,Followup
• Report Date (Section B): 01/29/2026

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: 430151-02
• Device Catalogue Number: 430151
• Device Lot Number: K10250515 0011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/24/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2025
• 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