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

Model Number	430011-62
Medical Device Problem Codes	Failure to Deliver Energy (1211); Energy Output Problem (1431)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted benign hysterectomy procedure, bleeding occurred while performing tissue dissection and hemostasis with the fenestrated bipolar forceps (fbf) instrument.The surgeon reported diminished energy output and reduced smoke generation during this event.Despite removing the instrument, thoroughly cleaning the jaws, and performing another coagulation attempt, the issue persisted.There were no collisions, thermal damage, or visible cables.The patient did not require a blood transfusion, as the bleeding was anticipated and considered minimal.To resolve the issue, a backup fbf instrument was used, and the procedure was successfully completed.There is no concern about this event causing any long-term complications, and the patient did not experience any post-operative complications.
Additional Manufacturer Narrative
The fenestrated bipolar forceps instrument was analyzed, and the complaint was not confirmed by failure analysis.Visual inspection was performed and no damage to the conductor wires was observed.The instrument was placed and driven on an in-house system.The instrument passed the recognition and engagement tests.The instrument was connected to the in-house erbe generator and passed energy recognition.The instrument moved intuitively with full range of motion in all directions.The grip tips opened and closed properly.Energy delivery was tested and passed in various grip orientations.The instrument passed the electrical continuity test.The instrument was fully functional.No product issue was identified.A review of the site's system logs for the reported procedure date was conducted and the investigation revealed there were no related system errors to have occurred during the surgical procedure that would have likely caused or contributed to the reported complaint.

• 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: 25229726
• Report Number: 2955842-2026-25761
• Device Sequence Number: 10183923
• Product Code: NAY
• UDI-Device Identifier: 00886874114339
• UDI-Public: (01)00886874114339(11)250109(10)K10250109
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K182371
• 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): 05/20/2026

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: K10250109 0002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2025
• 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: Female