MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI ENERGY; SYNCHROSEAL

Model Number	480440-07
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/23/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did not receive a da vinci product to perform failure analysis.The synchroseal instrument logs show that the instrument was installed 13 times.The e-100 generator logs show that the first instrument had 2 seal events with no errors and 711 transect events with 4 seal electrodes shorted errors, 2 cut electrodes shorted errors, and 1 ¿blank¿ error, indicating that 7 transect events likely did not fully go through.The logs show those cut and seal electrodes shorted errors at the same timestamps as one of those errors seen in e-100 generator logs.The e-100 recoverable error seen in the logs is at the same time stamp as that of the ¿blank¿ error.The instrument was used for about 3 hours 47 minutes.
Event or Problem Description
It was reported that during a da vinci-assisted pancreatoduodenectomy surgical procedure, the synchroseal instrument completely disintegrated intraoperatively.There was a total of 200 ml blood loss.No fragment fell into the patient.The procedure was completed with a new instrument.The following information is unknown: details regarding the disintegration of the instrument, the cause and source of the bleeding, and what medical intervention (if any) was rendered due to the complication.Intuitive surgical, inc.(isi) has attempted to gather additional information regarding the reported event; however, no response has been received.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h3, h6, h11.Device evaluation: intuitive surgical, inc.(isi) received the synchroseal instrument to perform failure analysis.A visual inspection revealed that the cut electrode was dislodged from its original position and was hanging outside the jaws.The cut electrode dislodged, and there may be missing pieces; however, the size of the missing pieces cannot be confirmed, indicating that a fragment may have detached from the instrument.Additionally, visual inspection found the cut electrode thermally damaged on the jaws.The instrument was found to have the washer dislodged from its original position and was still attached to the instrument.The jaw cover was moved to verify that the washer was still attached to the instrument and appeared to remain attached to the pivot pin.Additional information: isi followed up with the initial reporter and obtained the following additional information regarding the reported event: there was no reported dramatic bleeding as the bleeding was under control.The blood loss did not occur due to an isi product, or any anatomical factors.No fragment was reported to have been left in the patient.The jaw cover was not torn or damaged, therefore no arching was observed.It is unknown if the jaws encountered a clip, suture, staple or another metal object when the reported issue was noted.The instrument was inspected prior to use with no obvious damage noted.The patient's current status was not provided by the reporter, and no images or videos of this event were available for review.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: DA VINCI ENERGY
• Common Device Name: SYNCHROSEAL
• 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: 25020990
• Report Number: 2955842-2026-22902
• Device Sequence Number: 21240526
• Product Code: NAY
• UDI-Device Identifier: 10886874117306
• UDI-Public: (01)10886874117306(17)270731(10)K10250731
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K191280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification,Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 480440-07
• Device Catalogue Number: 480440
• Device Lot Number: K10250731 0293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/31/2026
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 04/28/2026
• Supplement Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2025
• 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: ISIFA2022-01-C
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown