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

Model Number	431150-01
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during central processing, the force bipolar instrument jaws were bent.There was no report of patient involvement or patient injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained additional information: the wrist of the instrument appears to be unhinged.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has received the force bipolar instrument associated with this complaint and completed investigations.The instrument was found to have severely bent grip tips.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 1.74 mm and 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, snake wrist and housing.Each input disk was manually articulated and no issues were found.The release buttons were functional.Additionally, the instrument was found to have a dislodged molded insulator on the jaw.Upon visual inspection, the upper molded insulator was found to be slightly dislodged, approximately less than 0.40 mm from the grip tips.The dislodged upper molder insulator is likely caused by the misalignment grip tips.Additionally, the instrument was found to have corroded bearings.The housing was removed for inspection and orange discoloration was observed on six bearings near the grip sector gear and input disks, which indicates corrosion.The complaint was confirmed by failure analysis.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.

• 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: 24858574
• Report Number: 2955842-2026-21262
• Device Sequence Number: 15762774
• Product Code: NAY
• UDI-Device Identifier: 00886874124055
• UDI-Public: (01)00886874124055(10)H11250903
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/13/2026

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: H11250903 0020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2025
• 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