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

Model Number	471205-19
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted pelvic exenteration surgical procedure, the fenestrated bipolar forceps instrument did not respond to the surgeon's commands and became stuck inside the patient's cavity.The customer was unable to remove it with the safety key.The customer utilized all skills to attempt removal but had to remove the trocar along with the forceps, making it necessary to open a new instrument set to complete the surgery.Intuitive surgical, inc.(isi) performed follow-up and obtained the following additional information regarding the reported event: the instrument would not move, and a nurse was brought in to do everything possible to free the instrument.The surgeon confirmed the patient suffered no harm.At the time of this report, the reason for the use of the instrument release kit (irk) has not yet been determined.
Additional Manufacturer Narrative
Intuitive surgical inc.(isi) has not received the da vinci product with an alleged issue to perform failure analysis.A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received.

• Brand Name: EndoWrist
• 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 ; +1(408)523-2100
• MDR Report Key: 50936287
• Report Number: 2955842-2026-39691
• Device Sequence Number: 16139714
• Product Code: NAY
• UDI-Device Identifier: 00886874119808
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K214095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 471205-19
• Device Catalogue Number: 471205
• Device Lot Number: K16251019 0131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2025
• 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
• Patient Sex: Unknown