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

Model Number	430151-02
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/13/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The fenestrated bipolar forceps instrument has not been received for failure analysis evaluation.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the plastic part of the fenestrated bipolar forceps tip was lost when it separated during the process of grasping the fibroid.It is unknown if a fragment was retrieved during the same procedure.The procedure was completed.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument was inspected before use and found to be in normal condition.During approximately one hour of use, while grasping tissue, an unknown issue caused a fragment of the device to fall inside the patient.No functional issues or collisions with other instruments were observed during the procedure, and the wrist was straightened upon removal without resistance or visible damage to the instrument or cannula.The fragment was not retrieved because it could not be located, and x-ray imaging was performed post-operatively, but no additional surgical procedures were required.The procedure was completed robotically with no injury to the patient, and the patient has not returned with post-surgical complications related to the retained fragment.The instrument is available for return to isi for evaluation, but photographic images or video recordings for isi review were not available.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h3, h6, and h11.Device evaluation: intuitive surgical, inc.(isi) received the fenestrated bipolar forceps instrument to perform failure analysis.The instrument was analyzed and found to have a broken molded insulator on the upper jaw.The broken piece measured approximately 1.72 mm x 6.48 mm, confirming that a fragment detached from the instrument.The fragment was not returned with the instrument.The grip base for the grip with the cracked molded insulator did not appear to be bent.The electrical continuity was performed and passed.The housing was removed and found to be undamaged.The inputs were manually articulated and passed.Additionally, the instrument was found to have a detached intact jaw due to the broken molded insulator.The jaw was completely detached from the grip base, but the conductor wire was still holding onto the grip.
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: 24544978
• Report Number: 2955842-2026-15400
• Device Sequence Number: 14852254
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2026

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 0035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2026
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 04/03/2026
• 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: Unknown