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

Model Number	VSTL45
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
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.There was a hair in the packaged with the device.Another like device was used to continue with the procedure.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.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: d9.Date device returned to manufacturer, d9.Is device returned to manufacturer?, h3.Reason for non- evaluation, h6.Type of investigation, h6.Investigation findings, h6.Investigation conclusions.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.Corrected information: d9.Device available for evaluation?, h3.Device evaluated by manufacturer?.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the product was returned for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that a vstl45 device was returned sterile with no apparent damage.Upon visual inspection of the package, a hair was noted inside of the package.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Although no conclusion could be reached on how the foreign matter was introduced inside the sterile package, it is possible that the hair adhered to the device during the packaging process due to static.The reported complaint was confirmed.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: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16548295
• Report Number: 2210968-2023-01723
• Device Sequence Number: 17652965
• Product Code: MZM
• UDI-Device Identifier: 10705031462724
• UDI-Public: 10705031462724
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/05/2023

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 Expiration Date: 02/28/2025
• Device Model Number: VSTL45
• Device Catalogue Number: VSTL45
• Device Lot Number: 5332669
• 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: 03/10/2023
• Supplement Date Received by Manufacturer: 04/18/2023; 05/03/2023
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 04/19/2023; 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2022
• 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