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

Model Number	430011-62
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The bipolar instrument was analyzed and found to have a bent grip tip.Visual inspection was performed and the lower grip tip was observed to be severely misaligned from its original position.The offset at the tips was approximately 1.45 mm, and the grips were not found to be cracked.The offset of the grip tip is likely to cause the dislodged molded insulator.There was no damage to the main tube, the snake wrist, or the housing.Each input disk was manually articulated, and no issues were found.The release buttons were functional.The instrument was found to have a dislodged molded insulator on the jaw.Upon visual inspection, the lower molded insulator was found to be slightly dislodged, approximately less than 0.30mm from the grip tips.The probable root cause of bent grips is attributed to damage during use, as moderate misalignment of grip tips can be due to grasping either hard tissue/objects or collisions with other instruments.This issue can be resolved by using an alternate instrument to complete the procedure.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the fenestrated bipolar forceps instrument tips do not align well.The procedure was completed with no reported injury.

• 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: 25155509
• Report Number: 2955842-2026-24816
• Device Sequence Number: 15783909
• Product Code: NAY
• UDI-Device Identifier: 00886874114339
• UDI-Public: (01)00886874114339(11)240711(10)K10240711(91)0003
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K182371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/12/2026

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: K10240711 0011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2024
• 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