MAUDE Adverse Event Report: ETHICON INC. VISTASEAL LAPAROSCOPIC DUAL APPLICATOR (35 CM RIGID); FIBRIN SEALANT PREPARATION DEVICE

Catalog Number	VSTL35
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
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 the customer have reported receiving a laparoscopic dual rigid applicator when they intended to purchase the laparoscopic dual flexible applicator.The lot number reported belongs to the laparoscopic dual flexible applicator not the laparoscopic dual rigid applicator.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.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).Additional information: 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, it was received that the customers have reported receiving product code vstl35 with lot number 5866415 when they intended to purchase product code vstl45.Lot number 5866415 belongs to vstl45 not vstl35.The labeling for product code vstl35 needs reviewing to ensure that it's labeled with the corresponding lot number.He also reported a possible widespread mislabeling issue with product code vstl35 which needs to be addressed to prevent further discrepancies.This is an analysis for a photo submitted to ethicon for evaluation.During the visual analysis, the following was observed: the photos shows a sales unit box with vstl35 product codes, the lot #5866415, expiration date 2028-03-31, packaging information.The image is not clear to determine the failure mode or the reported condition.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 5866415.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 (35 CM RIGID)
• 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: 22900362
• Report Number: 2210968-2025-09838
• Device Sequence Number: 20284335
• Product Code: MZM
• UDI-Device Identifier: 10705031462571
• UDI-Public: (01)10705031462571(17)280331(10)5866415
• Combination Product (Y/N): N
• 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
• 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: VSTL35
• Device Lot Number: 5866415
• 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: 08/06/2025
• Supplement Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 11/20/2025
• 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