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

Model Number VSTAS1

Device Problems Break (1069); Failure to Disconnect (2541)

Event Date 11/15/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information was requested, and the following was obtained: is the user a new user to vistaseal? if not, how many times have they used vistaseal prior to this event? yes.How many times have they applied the laparoscopic tip? first time.Was a sales representative present during the case when the issue was experienced? no.Was any leakage or product solution observed at the luer locks connection? no.Were there any unexpected outcomes or complications as a result of the event? no answer.Are there pictures of the damaged device available? no.Investigation summary: the following observations were made by inspecting the returned device: both of the adapter luer legs were broken as shown in.Thread on one of the manifold leg was stripped off backwards.The broken adapter luer legs were stuck into the female luers on the tip manifold.There are deep cuts or tool marks on the manifold.No inside damages were found on the grey luer locks.However, there were deep tool marks on the outside of the luer locks.Investigation: the tool marks on the luer locks indicate that a metal tool was used trying to pry off the luer locks.At least one luer lock was turned to the tighten direction with excessive force, causing the thread on the tip manifold to be stripped off to the backward direction.Once the thread was stripped off, the tip could not be removed from the adapter.The broken adapter luer legs, and the deep tool marks on the tip manifold, indicate that the tip was manipulated with excessive lateral force on the tip manifold, trying to wiggle the tip from side to side to remove the tip from the adapter, resulting the broken luer legs on the tip manifold.However, based on the complaint description, it is unknown why the user resorted to using a tool to unlock the tip.It is highly probable that the user initially tightened the luer locks instead of loosening them, causing the luer locks to get stuck, leading the user to use a tool to pry off the luer locks.Conclusions: it is determined that a tool was used with excessive force to turn the luer locks in the wrong direction.As a result, the luer locks and tip were stuck and the tip was unremovable/unexchangeable and the device unusable.User used a tool trying to wiggle the tip manifold side to side to remove the tip from the adapter.The excessive lateral force and movement broke the adapter legs.It is unknown why the user resorted to using a tool to unlock the tip.A manufacturing record evaluation was performed for the possible finished device lots, and no non-conformances were identified.Additional information: the actual device batch number associated with this event is not known.The international affiliate reports the following possible batch numbers: batch 2631478, mfg date: may 09, 2020 - may 15, 2020, exp date: may 10, 2023.Batch 2623188, mfg date: april 19, 2020 - april 25, 2020, exp date: april 20, 2023.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that a patient underwent a robotic laparoscopic sleeve gastrectomy procedure on (b)(6) 2021 and a fibrin sealant preparation device was used.The scrub tech had difficulty removing the lure locks, while attempting to attach the laparoscopic tip.The scrub tech ended up breaking the luer locks.The product was thawed and not frozen when attempting remove the lure locks.Another like device was used to complete the procedure.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: VISTASEAL DUAL APPLICATOR
• Type of Device: 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: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13765345
• MDR Text Key: 287199802
• Report Number: 2210968-2022-01789
• Device Sequence Number: 1
• Product Code: MZM
• UDI-Device Identifier: 10705031462533
• UDI-Public: 10705031462533
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: BK180287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Report Date: 03/14/2022

1 Device was Involved in the Event

• Date FDA Received: 03/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VSTAS1
• Device Catalogue Number: VSTAS1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2022
• Date Manufacturer Received: 11/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial