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

Model Number	VSTL35
Medical Device Problem Code	Failure to Disconnect (2541)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2020
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: if the tip used is laparoscopic tip please indicate how many units of airless spray tip came with the original packaging? 3.What is the product code of the laparoscopic tip? (b)(4).What is the lot number of the laparoscopic tip? unknown.Is the device available to be returned for evaluation? no.
Event or Problem Description
It was reported that a patient underwent a robotic inguinal hernia procedure on (b)(6) 2020, and a fibrin sealant preparation device was used.During the procedure the luer lock would not open, and the tip would not twist.As a consequence, the laparoscopic applicator could not be attached.The surgeon had to use a clamping device to eventually get the tip on to the device, and the procedure was completed with no patient consequences.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 1/19/2021.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 R
• Common Device Name: FIBRIN SEALANT PREPARATION DEVICE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10911254
• Report Number: 2210968-2020-09399
• Device Sequence Number: 3216855
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2020

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: 10/30/2020
• Supplement Date Received by Manufacturer: 12/28/2020
• Initial Report FDA Received Date: 11/26/2020
• Supplement Report FDA Received Date: 01/19/2021
• Patient Sequence Number: 1