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

Catalog Number	VSTL35
Medical Device Problem Codes	Failure to Disconnect (2541); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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.
Event or Problem Description
It was reported that a patient underwent a laparoscopic gastric bypass procedure on (b)(6) 2023 and a fibrin sealant preparation device was used.The tech had difficulty connecting applicator to pre-filled syringe.They got another applicator to proceed with the case.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: d 9.Date device returned to manufacturer, d 9.Is device returned to manufacturer? h6 component code: g07002 - no device problem found.Investigation summary: the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the vstl35 device was returned attached to the adapter and syringe holder, pre-filled syringes empty.In an attempt to replicate the reported incident, the device was functionally tested to detect any functional issues.Upon evaluation of the device, it was functionally tested, and the luers move correctly and can be both tightened and loosened without issues observed.The device was fully functional according to the manufacturing requirements.As part of ethicon¿s quality process all devices are manufactured, inspected, and released to approved specifications.No conclusion could be reached as to what may have caused the reported incident.The reported complaint could not be confirmed.Per instructions for use: ¿loosen the luer locks to remove the spray and drip tip from the adapter, attach the vistaseal laparoscopic dual applicator to the adapter by tightening the luer lock¿.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: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18651587
• Report Number: 2210968-2024-00988
• Device Sequence Number: 20859948
• Product Code: MZM
• UDI-Device Identifier: 10705031462571
• UDI-Public: 10705031462571
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 03/05/2024

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: 5615153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2024
• Supplement Date Received by Manufacturer: 02/12/2024
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2023
• 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