MAUDE Adverse Event Report: ETHICON INC. VISTASEAL DUAL APPLICATOR; FIBRIN SEALANT PREPARATION DEVICE

Catalog Number	VSTAS1
Medical Device Problem Code	Failure to Disconnect (2541)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a robotic hysterectomy procedure on (b)(6) 2025 and a fibrin sealant preparation device was used.During the procedure they could not get the gray tip off the fibrin sealant preparation device.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).D4: full udi currently unavailable since the exact lot of the suspected device cannot be determined.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.Additional information was requested, and the following was obtained: 1.Is the user a new user to vistaseal? if not, how many times have they used vistaseal prior to this event? many times, and rep was in the room assisting.After we determined the gray knobs were ¿stuck¿ (especially with gloves on) it was passed off to the rep to see if i could unscrew them.It took excessive force especially with gloves on.2.How many times have they applied the laparoscopic tip? countless 3.Was a sales representative present during the case when the issue was experienced? yes 4.Was any leakage or product solution observed at the luer locks connection? it never was expressed as it was to be used robotically.5.Were there any unexpected outcomes or complications as a result of the event? added or time.6.Are there pictures of the damaged device available? no, device is available for testing.7.Is the device available to be returned for evaluation? if so, please provide the status of the return and any available tracking information.Yes.Waiting for box with label.8.Please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep) rep was in case.Product was submitted by (b)(6).Additional information: d4 ¿ the actual device batch number associated with this event is not known.The following are the possible batch numbers: 3579223 and 3582317.This report is being submitted pursuant to the provisions of 21 cfr part 803, part 4 subpart b.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).D4: full udi currently unavailable since the exact lot of the suspected device cannot be determined.A manufacturing record evaluation was performed for the possible finished device lots, and no non-conformances were identified.Additional information: d4, h4 ¿ the actual device batch number associated with this event is not known.The following are the possible batch numbers: batch 3579223 mfg date: 7/27/2024, exp date: 7/28/2029.Batch 3582317 mfg date: 7/31/2024, exp date: 7/31/2029.This report is being submitted pursuant to the provisions of 21 cfr part 803, part 4 subpart b.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 9.Device available for evaluation?, h 3.Device evaluated by manufacturer? additional information: h 6.Component code, h 6.Type of investigation, h 6.Investigation findings, h 6.Investigation conclusions 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 vstas1 device was returned without the airless spray tip and attached to the syringe holder with pre-filled syringe with component.In addition, the secondary box and tyvek were returned along with the instrument.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.This report is not intended to deny that you experienced a problem with the device.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.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¿.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.Based on the results of this investigation, it was determined that the product met the manufacturing release criteria: since no malfunction was observed during the investigation.No corrective and preventive action (capa) is required now.Analysis does not confirm (verify) the reported failure.No further investigation will be conducted on this complaint.Complaint information will be included in complaint trending that is reviewed by the applicable product quality safety surveillance data review board on a regular basis to determine if further action is necessary.Additional information was requested, and the following was obtained: lnstituto grifols, s.A.(ig) upon the reception of the notified incident, it was requested additional information such as the experience of the user with the product, the presence of any leakage observed at the connection, as well as the availability of pictures/sample of the involved device.The following additional information was received: the user had extensive experience with the product no leakage was observed at the luer locks connection.There are no pictures of the involved device, but the sample was available for evaluation.According to our standard procedures, ig initiated an investigation focused on: evaluation of the returned sample at (b)(6) facilities: the investigation conducted by ethicon indicated the following: visual analysis of the returned sample determined that the dual applicator device was returned without the airless spray tip and attached to the syringe holder with pre-filled syringe with component.In addition, the secondary box was returned along with the instrument.In an attempt to replicate the reported incident, the device was functionally tested (unscrew the luer locks) to detect any issue.Upon evaluation of the device, 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.According to ethicon's investigation no conclusion could be reached as to what may have caused the reported incident.The reported complaint could not be confirmed.Investigation of the dual applicator tip: considering the nature of the reported incident, it was requested to ethicon to carry out an investigation of the batch of tips involved, as ethicon is the supplier of vistaseal dual applicator.The investigation was focused on reviewing the results of batch records for the batch of tips used.Ethicon concluded that all the components parts utilized for the involved batch met the established specifications with no incidents related.Results of quality control performed at (b)(6) facilities: lnstituto grifols, s.A.Reviewed the results of the quality controls performed to the incoming materials (tips) involved in the notification.A review of the results related to the luer lock functionality performed to incoming tips kitted with the involved batch, a04j156601, was performed.The results were found correct within specifications and no deviations were detected.Even though a definitive root cause cannot be determined, considering that there were no evidences detected during the manufacturing process of the tips, and the results of the incoming inspection of the tips were correct, it can be concluded that the reported notification is not related to the quality of the components used.However, in order to record the reported incident related to the dual applicator, ig will track it in their system for monitoring with the supplier of the related tips.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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 DUAL APPLICATOR
• Common Device Name: FIBRIN SEALANT PREPARATION DEVICE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): TESSY PLASTICS CO. LTD; 509 ren qing road; pudong 20120 1; CH 201201
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 22023076
• Report Number: 2210968-2025-05370
• Device Sequence Number: 9484062
• Product Code: MZM
• UDI-Device Identifier: 10705031462533
• UDI-Public: 10705031462533
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: BK180287
• 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
• Report Date (Section B): 08/28/2025

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: VSTAS1
• Device Lot Number: 3579223, 3582317
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2025
• Supplement Date Received by Manufacturer: 05/29/2025; 08/26/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 06/24/2025; 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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