MAUDE Adverse Event Report: ETHICON INC. VISTASEAL LAPAROSCOPIC DUAL APPLICATOR (45 CM FLEXIBLE); FIBRIN SEALANT PREPARATION DEVICE

Catalog Number	VSTL45
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
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 an unknown procedure on an unknown date and fibrin sealant preparation device was used.When they opened the box that came with the fibrin sealant device outside the shipping label, the actual device received.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint #(b)(4).D4: udi: the expiration date is currently not available.Therefore, 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: please clarify, was the shipping box labelled as vstl45, but a vstl35 product box was found within holding a vstl35 laparoscopic applicator or was the incorrect product.(vstl35) found within a vstl45 product box? yes, a vstl45 box had the wrong product.It had 3 vstl35 lap applicators instead of 3 vstl45 lap applicators.¿ what is the lot number? 5881559.¿ was the product seal on the box still intact when the package was opened? yes, seal was intact.This report is being submitted pursuant to the provisions of 21 cfr part 803.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).Corrected information: d 4.Primary udi number, additional information: d 4.Expiration date, h 4.Device manufacture date, h 6.Type of investigation, h 6.Investigation findings, h 6.Investigation conclusions, h 6.Component code.H 6.Investigation findings: c22 ¿ photo investigation c22 photo investigation summary = > according to the information received, that when they opened the box that came with vstl45 outside the shipping label, the actual device received (vstl35) was incorrect.No product is available for return.No patient was involved.They just wanted to report what happened.This is an analysis for a photo submitted to ethicon for evaluation.During the visual analysis, the following was observed: the photos shows two sales unit boxes with vstl35 product codes, the lot 5881559 #, expiration date 2028-03-31, packaging information.Based on the photo review, the event reported is not confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the device was not returned our evaluation is limited.We value the opportunity to fully analyze the device upon its return.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.We value your assistance in providing us an opportunity to evaluate the reported event as all information reported to our company is critical to our continuous improvement efforts.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.A review of the device batch record was performed for raw materials, in-process and finished goods for lot number 5881559.Capa-03781 was opened.The devices met all raw materials, in-process and finished goods specifications upon release of the product.This report is being submitted pursuant to the provisions of 21 cfr part 803.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 LAPAROSCOPIC DUAL APPLICATOR (45 CM FLEXIBLE)
• Common Device Name: FIBRIN SEALANT PREPARATION DEVICE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): VIANT AS&O HOLDINGS INC.; 45 lexington drive; laconia NH 03246
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 22436540
• Report Number: 2210968-2025-07937
• Device Sequence Number: 3152552
• Product Code: MZM
• UDI-Device Identifier: 10705031462724
• UDI-Public: (01)10705031462724(17)280331(10)5881559
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: BK190324
• 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): 11/20/2025

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: VSTL45
• Device Lot Number: 5881559
• 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: 07/03/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/29/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown