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

Model Number	480440-07
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted hiatal hernia paraesophageal surgical procedure, a piece of the clamp at the level of one of the two jaws broke off.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did not receive the da vinci product with an alleged issue to perform failure analysis.

• 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: 25238087
• Report Number: 2955842-2026-25871
• Device Sequence Number: 18573139
• Product Code: NAY
• UDI-Device Identifier: 10886874117306
• UDI-Public: (01)10886874117306(10)K10250718
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K191280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/20/2026

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: 480440-07
• Device Catalogue Number: 480440
• Device Lot Number: K10250718
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2025
• 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 Age: 81 YR
• Patient Sex: Male
• Patient Weight: 79 KG