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

Model Number	430011-62
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information on 13-jan-2026: the dislocation at the distal end of the instrument resulted to its part being broken.There was no patient injury or harm.The instrument was replaced with a new one to complete the procedure.
Additional Manufacturer Narrative
The instrument involved in this complaint has not been received and/or tested by failure analysis as of the date of this report.If the product is received and evaluated, a supplemental mdr will be submitted.
Event or Problem Description
It was reported that during a da vinci-assisted myomectomy surgical procedure, the 6mm single-port (sp) fenestrated bipolar forceps instrument tip was dislocated.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
Additional information was obtained from quality engineer (qe) investigation: while a definitive root cause cannot be established since the product was not returned for failure analysis, the potential root cause of the broken tip can be attributed to damage during use, which may result from applying excess force on the instrument tip during handling, insertion, usage (overloading), or removal.Annex c and d codes were updated based on investigation results.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis, and the complaint was confirmed.The fenestrated bipolar forceps (from single port system) instrument was analyzed and found to have a dislodged proximal clevis.The dislodged proximal clevis was found at weld 4, the location of the distal main tube.The welds were inspected and appeared to be present on both sides and did not show signs of workmanship or burn-back issues.The distal grip tips were still attached to the instrument due to the internal components, and no material was found missing.Additionally, the instrument was found to have mechanical indentations.The mechanical indentations were found at the where the proximal clevis and disc meet, at weld 4 of the distal main tube.The probable root cause of the dislodged proximal clevis is attributed to damage during use.Applying excessive force on the distal end of the instrument during handling, insertion, usage (overloading), or removal can cause damage.
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: 24050519
• Report Number: 2955842-2026-01167
• Device Sequence Number: 15916636
• Product Code: NAY
• UDI-Device Identifier: 00886874114339
• UDI-Public: (01)00886874114339(10)K10250401
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K182371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/07/2026

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: 430011-62
• Device Catalogue Number: 430011
• Device Lot Number: K10250401 0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/23/2025
• Supplement Date Received by Manufacturer: 01/13/2026; 02/23/2026; 03/13/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 01/22/2026; 02/27/2026; 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2025
• 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: Female