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

Catalog Number	VSTAS1
Medical Device Problem Code	Failure to Disconnect (2541)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a general surgery procedure on (b)(6) 2025 and a fibrin sealant preparation device was used.During general surgery under robotic assistance, the staff could not remove the open applicator tip in order to put on the laparoscopic tip.The grey luer lock was stuck.The case was completed by opening another like device.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.H6.Component code: g07002 - device not returned.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested, and the following was obtained: is the user a new user to vistaseal? no if not, how many times have they used vistaseal prior to this event? unknown.How many times have they applied the laparoscopic tip? unknown.Was a sales representative present during the case when the issue was experienced? no.What is the lot number? unknown.Was any leakage or product solution observed at the luer locks connection? no.Were there any unexpected outcomes or complications as a result of the event? no.Are there pictures of the damaged device available? no.Is the device available to be returned for evaluation? if so, please provide the status of the return and any available tracking information.Not available.This report is being submitted pursuant to the provisions of 21 cfr part 803, part 4 subpart b.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).D4 udi number: udi/gtin unavailable as this device is from a kit.Additional information received: institute grifols, s.A.(ig) upon receipt of the reported incident, additional information was requested to support the investigation, including the device batch number, the device presentation, the user experience with the device and any observed leakage on the connection.It was also requested information regarding the availability of pictures and a confirmation of the sample return availability.The following information was received: ¿ no leakage was observed.¿ no pictures or the device were available.¿ the batch number, product format, and other relevant details were not provided.As no further information has been received to date and the related sample is not available, ig has been unable to conduct a proper investigation.Consequently, the complaint will be closed.Please note that if any additional information is received that may support a proper investigation, the case may be reopened.This report is being submitted pursuant to the provisions of 21 cfr part 803, part 4 subpart b.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: VISTASEAL DUAL APPLICATOR
• Common Device Name: FIBRIN SEALANT PREPARATION DEVICE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): TESSY PLASTICS CO. LTD; 509 ren qing road; pudong 20120 1; CH 201201
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 22673929
• Report Number: 2210968-2025-08866
• Device Sequence Number: 15325007
• Product Code: MZM
• UDI-Device Identifier: 10705031462533
• UDI-Public: 10705031462533
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: BK180287
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2025

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: Health Professional
• Device Catalogue Number: VSTAS1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2025
• Supplement Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown