MAUDE Adverse Event Report: ETHICON INC. ETHICON VISTASEAL; FIBRIN SEALANT PREPARATION DEVICE

Model Number	VSTAS1E
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Vistaseal fibrin sealant was requested for use during surgery, but after putting the kit together, the sealant wouldn't dispense.A new kit was opened and used.

• Brand Name: ETHICON VISTASEAL
• Common Device Name: FIBRIN SEALANT PREPARATION DEVICE
• Manufacturer (Section D): ETHICON INC.; 1000 us highway 202 s.; raritan NJ 08869
• MDR Report Key: 23014879
• Report Number: 23014879
• Device Sequence Number: 9741571
• Product Code: MZM
• UDI-Device Identifier: 10705031462533
• UDI-Public: (01)10705031462533
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/04/2025
• Report Date (Section F): 09/04/2025

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: Other
• Device Model Number: VSTAS1E
• Device Catalogue Number: VSTAS1E
• Device Lot Number: A04J176611
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/10/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/10/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Date Report Sent to FDA: 09/04/2025