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

Model Number	VSTL35
Medical Device Problem Codes	Leak/Splash (1354); Connection Problem (2900); Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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: what is the lot number of the vst10 device? a4yde00621 what is the lot number of the vstl35 laparoscopic tip? unknown.What was the thawing process used? warm bath: yes.Temperature: unknown.For how long (in minutes)?: approximately 5 minutes.Was the product thawed with or without blister?: without.Room temperature: n/a.Temperature: n/a.For how long (in minutes)?: n/a.What was the appearance of the product after thawing? clear.Please specify how long was the biologic thawed prior to attempt use? unknown.Was there any observation around the plunger being depressed prior to spraying (during setup or inadvertently pressing during handling before application)? unknown.How was the fibrin sealant applied? did the surgeon press firmly on the plunger or soft in order to weaken the spray pattern? pa applied fibrin sealant; applied via spray, pressed firmly but difficult to express.Was the device purged of air prior to installing the dual applicator? no.Are there pictures of the damaged devices available? no.Was there any change in the patient¿s post-operative care due to the prolonged procedure? unknown.What is the patient¿s age/dob and/or gender? unknown.Please clarify, did the product form a clot? it did not appear to form a clot.Was hemostasis achieved? there was no active bleeding at the time.14.Were there any consequences on the patient? no.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 sleeve gastrectomy on an unknown date and a fibrin sealant preparation device was used.The fibrin sealant preparation device was set up on the back table by the scrub tech to be used over the staple line.The device was introduced through a 5mm trocar by the pa and the plunger was depressed to express the product.The pa noted that the plunger was difficult to depress during the expression.There was leaking from the connection of the assembly to the fibrin sealant preparation device.The purple plunger cap dislodged from the pre-filled syringe.The pa noted that while it appeared that the biologics were expressed, there did not appear to be a clot formed over the staple line.A new fibrin sealant preparation device was used to complete the case with no patient consequences.The procedure was delayed by ten minutes.Additional information was requested.

• Brand Name: VISTASEAL LAPAROSCOPIC DUAL APPLICATOR R
• Common Device Name: FIBRIN SEALANT PREPARATION DEVICE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12510967
• Report Number: 2210968-2021-08739
• Device Sequence Number: 19810345
• Product Code: MZM
• UDI-Device Identifier: 10705031462571
• UDI-Public: 10705031462571
• Combination Product (Y/N): N
• 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: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/25/2021

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 Model Number: VSTL35
• Device Catalogue Number: VSTL35
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2021
• Initial Report FDA Received Date: 09/21/2021
• Patient Sequence Number: 1