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

Model Number	430151-02
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/27/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the sp fenestrated bipolar forceps (fbf) instrument for failure analysis evaluation.The sp fbf instrument passed both continuity and energy delivery tests.It was placed and tested on an in-house system, where it also passed both the recognition and engagement tested.The sp fbf instrument demonstrated intuitive movement with a full range of motion in all directions, and the grips opened and closed properly.The sp fbf instrument was retested and again passed all in-house tests on both attempts, confirming full functionality with no physical damage observed.The housing was removed for further inspection, revealing no damage or product issues.
Event or Problem Description
It was reported that during a da vinci-assisted ovarian cystectomy procedure, the sp fenestrated bipolar forceps (fbf) instrument did not deliver energy when bipolar activation was attempted to achieve hemostasis.Troubleshooting steps included increasing the bipolar energy setting from 3 to 4 and then to 5, as well as replacing the bipolar cable.Despite these efforts, the issue persisted.Upon visual inspection of the instrument, the sp fbf instrument sheath was removed, and there was no breakage or visible damage to the wire; however, the wire appeared to be "stretched." to resolve the issue, the sp fbf instrument was replaced with an unspecified robotic bipolar instrument.The procedure was completed robotically without further complications.The following information is unknown: the source and cause of the bleeding, what surgical task was being performed when the complication occurred, or the estimated blood loss associated with the bleeding.

• 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: 24945983
• Report Number: 2955842-2026-22278
• Device Sequence Number: 15973632
• Product Code: NAY
• UDI-Device Identifier: 00886874123447
• UDI-Public: (01)00886874123447(11)250904(10)K10250904
• 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
• Report Date (Section B): 04/21/2026

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: K10250904 0027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2025
• 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