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

Catalog Number	VSTL45
Medical Device Problem Code	Failure to Disconnect (2541)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a robotic extended right colectomy procedure on (b)(6) 2025 and a fibrin sealant preparation device was used.The luer locks are not working appropriately.You can attach the device, but you cannot detach the device.Case converted to an open case.Device was used with the long tip.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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.1.What is the product code of the vistaseal kit used (vst02, vst04, vst10)? 2.What is the lot number of the vistaseal kit? 3.Did the vstas1 dual applicator tip that experienced the quality issue come from a 3 pack of tips sold separately or a vistaseal kit? 4.Is the user a new user to vistaseal? if not, how many times have they used vistaseal prior to this event? 5.How many times have they applied the laparoscopic tip? 6.Was a sales representative present during the case when the issue was experienced? 7.Did the case converted to an open case because of the device malfunction? 8.Was any leakage or product solution observed at the luer locks connection? 9.Were there any unexpected outcomes or complications as a result of the event? 10.Are there pictures of the damaged device available? 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 3.Manufacturer email, d 4.Expiration date, d 9.Device available for evaluation?, h 4.Device manufacture date.Additional information: d 9.Date device returned to manufacturer, d 9.Is device returned to manufacturer?, h 6.Component code, h 6.Type of investigation, h 6.Investigation findings, h 6.Investigation conclusions.H6 component code: g07002 - pending evaluation of returned device.The device upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.A review of the device batch record was performed for raw materials, in-process and finished goods for lot number 5832134 and there were no non-conformances or capa¿s opened in relation to the nature of the complaint.The devices met all raw materials, in-process and finished goods specifications upon release of the product.Job 5832134 was manufactured on 2024-11-22 with an expiration date of 2027-10-31.A total of 240 3-packs were released to distribution on 2024-12-26.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: b1.Is adverse event, h1.Type of reportable event.Additional information: b2.Is required intervention, h6.Health effect - impact code.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).H3 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 vstl45 device was returned without the airless spray tip and attached to adapter with the luer locks damaged and to the the syringe holder with 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 but cannot remove the laparoscopic dual applicator flexible from the adapter.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 was confirmed.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.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.Health effect - impact code.Additional information was requested, and the following was obtained: 1.Does the surgeon believe that the experience with the device was the cause behind the robotic extended right colectomy procedure being converted to open? no.2.What is the product code of the vistaseal kit used (vst02, vst04, vst10)? vst10.3.What is the lot number of the vistaseal kit? not available.4.Did the vstas1 dual applicator tip that experienced the quality issue come from a 3 pack of tips sold separately or a vistaseal kit? came with the vst10 kit.5.Is the user a new user to vistaseal? if not, how many times have they used vistaseal prior to this event? hundreds of times.Experienced scrub tech.6.How many times have they applied the laparoscopic tip? hundreds of times.7.Was a sales representative present during the case when the issue was experienced? yes.8.Did the case converted to an open case because of the device malfunction? no.9.Was any leakage or product solution observed at the luer locks connection? no.10.Were there any unexpected outcomes or complications as a result of the event? delayed the procedure by 4 minutes.11.Are there pictures of the damaged device available? no.12.Is the device available to be returned for evaluation? if so, please provide the status of the return and any available tracking information.No.13.Please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep) (b)(6), certified scrub tech.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: h 1.Type of reportable event.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: 21700948
• Report Number: 2210968-2025-03203
• Device Sequence Number: 20998741
• Product Code: MZM
• UDI-Device Identifier: 10705031462724
• UDI-Public: (01)10705031462724(17)271031(10)5832134
• 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,Followup,Followup,Followup
• Report Date (Section B): 06/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: VSTL45
• Device Lot Number: 5832134
• 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: 03/19/2025
• Supplement Date Received by Manufacturer: 04/24/2025; 06/05/2025; 04/24/2025; 06/12/2025; 06/19/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 04/30/2025; 06/11/2025; 06/11/2025; 06/12/2025; 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown