MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI ENERGY; VESSEL SEALER CURVED

Model Number	480522-02
Medical Device Problem Code	Failure to Seal (4070)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An intuitive surgical, inc.(isi) field service engineer (fse) contacted the customer and was told the issue was resolved over the phone.No site visit was required.An advanced vessel sealer instrument log review was completed by failure analysis engineering.E-200 activation events for this procedure show 15 bipolar events with no errors and 85 seal events with 1 error.The instrument was used for about 58 minutes.Nothing in the log's pointed to a possible definitive causality pertaining to the customer¿s complaint.The probable root cause of the customer-reported event based on evaluation of instrument logs by failure analysis engineering may possibly be due to the high impedance event which typically occurs due to the user trying to seal excessive tissue.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the customer was not getting hemostasis when using a curved vessel sealer instrument.The customer inquired on where to plug in the instrument on the dv5 system.The intuitive surgical, inc.(isi) technical support engineer (tse) informed the customer that they needed to connect the instrument to the e-200 generator.The customer confirmed that the instrument was plugged into the lower bipolar port.The tse recommended to try the top bipolar port or a new instrument.The tse informed the customer that they could connect the backup e-200 if the issue continued.The procedure was completing as planned with no reported injury.

• Brand Name: DA VINCI ENERGY
• Common Device Name: VESSEL SEALER CURVED
• 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: 24491574
• Report Number: 2955842-2026-14703
• Device Sequence Number: 16123559
• Product Code: NAY
• UDI-Device Identifier: 10886874123369
• UDI-Public: (01)10886874123369(10)U10250902
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K250674
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/02/2026

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: 480522-02
• Device Catalogue Number: 480522
• Device Lot Number: U10250902 0215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/02/2025
• 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: Female