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

Model Number	431150-01
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The extended range force bipolar instrument was found to have one severely bent grip, causing misalignment of the grip-tips.There was a 2.70mm offset at the tips.The instrument was installed on an in-house system and passed the recognition and engagement test.The instrument moved with a full range of motion in all directions.The instrument grips were not found to be stuck.The complaint was confirmed by failure analysis.The probable root cause of bent grip 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.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure that the tip of the force bipolar instrument was found to be misaligned; the jaws would not open.The procedure was completed with no reports of patient injury.Intuitive followed up with the customer and was advised that there is no additional information available.

• 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: 23028631
• Report Number: 2955842-2025-37297
• Device Sequence Number: 9681808
• Product Code: NAY
• UDI-Device Identifier: 00886874124055
• UDI-Public: (01)00886874124055(10)H10250327
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/15/2025

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: H10250327 0008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2025
• 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: Reuse
• 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