MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST SP; FORCE BIPOLAR ER

Model Number	431150-01
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to the start of a da vinci-assisted surgical procedure, the force bipolar instrument's jaws were bent.The procedure was completed with no reported injury.Isi followed up with the initial reporter and obtained the following additional information: the instrument's wrist does not appear to be unhinged.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The force bipolar instrument was analyzed and found to have a severely bent grip tip.A 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 1.57 mm and the grips were 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, snake wrist or housing.Each input disk was manually articulated and no issues were found.The release buttons were functional.Upon visual inspection, the lower molded insulator was found to be slightly dislodged, approximately less than 0.40mm from the grip tips.The complaint was confirmed by failure analysis.The probable root cause of severely bent grips is attributed to damage either during use or reprocessing, as severe misalignment of grip tips can be due to accidental drops, incorrect instrument tray or sink sizes for reprocessing, or overloading the tips.

• Brand Name: ENDOWRIST SP
• Common Device Name: FORCE BIPOLAR ER
• 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: 25036994
• Report Number: 2955842-2026-23340
• Device Sequence Number: 21413782
• Product Code: NAY
• UDI-Device Identifier: 00886874124055
• UDI-Public: (01)00886874124055(10)H10250725
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K241814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/29/2026

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: 431150-01
• Device Catalogue Number: 431150
• Device Lot Number: H10250725 0016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2025
• 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