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	03/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure during a kidney operation, the customer was placing the specimen in the specimen bag.Then the operator discovers a small metal ring/rubber ring loose in the abdomen and wonders what this was.The customer checked the robotic instruments and concluded that the small ring comes from the synchroseal.The metal ring was taken out and the synchroseal was saved for a complaint to intuitive.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument was inspected prior to use, and no abnormalities were noted.After approximately two hours of use during a nephrectomy involving a large kidney and substantial surrounding tissue, the surgeon reported the breakage issue, believing it stemmed from an internal problem with the instrument itself.Although the instrument collided with other instruments during the procedure, no issues with its functionality were observed, and no fragments fell inside the patient.The instrument was not removed before the breakage as only the specimen placement remained.No post-operative imaging was performed to check for fragments, and the procedure was completed robotically without need for conversion.The patient has not returned with any post-surgical complications related to retained fragments.The instrument and fragment are scheduled to be collected for evaluation, and photographic and video documentation are available for review.
Additional Manufacturer Narrative
The synchroseal instrument has not been received for failure analysis evaluation.

• 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: 24879429
• Report Number: 2955842-2026-21288
• Device Sequence Number: 21063215
• Product Code: NAY
• UDI-Device Identifier: 10886874117306
• UDI-Public: (01)10886874117306(17)271031(10)K10251016
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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): 04/14/2026

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: K10251016
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/16/2025
• 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 Age: 42 YR
• Patient Sex: Unknown
• Patient Weight: 120 KG