MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC Endowrist; VESSEL SEALER EXTEND

Model Number	480422-03
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the vessel sealer extend (vse) instrument installed on universal surgical manipulator (usm) 4 was not opening and closing the tips.The customer manually closed the vse instrument using the release mechanism while the surgeon activated the energy.The customer stated that prior to calling technical support engineer (tse) for troubleshooting assistance, they tried to reset the vse instrument, but the issue persisted.The tse asked if it was possible to change the vse instrument and customer stated that it was not possible.During a second call, the customer plugged the cable for live logs.The tse suggested to verify the vse instrument during other procedure.Logs did not show any errors.The procedure was completed and no known impact or patient consequence was reported.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the vessel sealer extend (vse) instrument was inspected prior to use and nothing out of the ordinary was observed.The complete vse instrument batch number was no longer available.The vse instrument did not work at all (sealed successfully) during the procedure.A no sealing error occurred.At the time of the event, during the sealing sequence, there was normal tone.The seal cycle was completed with the fast audible tones as expected.The jaws could be opened again but not totally with the release key.The jaws did not come into contact with a clip, suture, staple, or other metal objects when the reported issue was noted.The vse was not longer available for return.The vse instrument had insufficient sealing.The vse worked properly for half part of the surgery but the real problem at the end was that the tips remained closed.The tone was properly during the sealing and at the end of the cut.The vse instrument sealed as expected in all attempts but the tips remained closed and they use the key to open them.The tissue effect observed was normal during the sealing cycle.There was no tissue cut that was not fully sealed.There was no unexpected bleeding.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did not receive the da vinci product with an alleged issue to perform failure analysis.

• Brand Name: Endowrist
• Common Device Name: VESSEL SEALER EXTEND
• 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 ; +1(408)523-2100
• MDR Report Key: 50214930
• Report Number: 2955842-2026-35285
• Device Sequence Number: 20358215
• Product Code: NAY
• UDI-Device Identifier: 10886874115661
• UDI-Public: (01)10886874115661(10)K17260130
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K173337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/11/2026

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: 480422-03
• Device Catalogue Number: 480422
• Device Lot Number: K17260130 0282
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/22/2026
• Initial Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/29/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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