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	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a gyn procedure on an unknown date and a fibrin sealant preparation device was used.During the procedure, they were trying to disconnect the open spray tip on the fibrin sealant preparation device and the leur locks locked up on them.They had to eventually use a clamp to open the leur lock, which was needed to address attaching the laparoscopic tip.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.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: · did the event occur during one or multiple patient procedures? x 3.· what is the total number of procedures? x 3.· have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).No.· please provide the following information for each patient event: 1.Is the user a new user to vistaseal? if not, how many times have they used vistaseal prior to this event? multiple times , more than 10.2.How many times have they applied the laparoscopic tip? all the cases.3.Was a sales representative present during the case when the issue was experienced? no.4.What is the product code (vst02, vst04, or vst10)? vst04.5.What is the lot number? all are discarded , i do not have one to report it out.6.Was any leakage or product solution observed at the luer locks connection? leakage noticed.7.Were there any unexpected outcomes or complications as a result of the event? no 8.Are there pictures of the damaged device available? no.9.Is the device available to be returned for evaluation? if so, please provide the status of the return and any available tracking information.No.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).Additional information was requested, and the following was obtained: lnstituto grifols, s.A.(ig) received a notification through ethicon related to one unit of vistaseal 4ml, batch number unknown, where it was reported that they were trying to disconnect the open spray tip and the luer locks were blocked.There were no adverse consequences for the patient.Upon the reception of the notified incident, it was requested additional information such as the batch number of the affected unit, the experience of the user with the product, if any leakage was observed as well as pictures/samples of the involved device.The following additional information was received : ¿ the user is not new.¿ the batch number is unknown, and the product was discarded.¿ there are no pictures of the involved unit.Since the batch number is unknown and there are no pictures available to date, it has not been possible for ig to perform a proper investigation.Based on this, we proceed to close the complaint.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: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 21515467
• Report Number: 2210968-2025-02310
• Device Sequence Number: 4449080
• Product Code: MZM
• UDI-Device Identifier: 10705031462533
• UDI-Public: 10705031462533
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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): 03/12/2025

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: 02/25/2025
• Supplement Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 03/12/2025
• 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