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

Model Number	VSTL35
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/23/2020
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: no other information was able to be gathered other than dr.(b)(6) was the surgeon.What is the lot number? n/a.Were there any patient consequences? n/a.How was the product thawed? were the biologics subjected to temperatures above 37c or 98f during the thawing process? n/a.Was there any observation around the plunger being depressed prior to spraying (during setup or inadvertently pressing during handling before application)? n/a.Was the device clogged? n/a.Did the surgeon try to force through a clog? n/a.Was the device purged of air prior to installing the dual applicator? n/a.Please identify where the breakage occurred (blister where fibrin sealant is located, prefilled syringe, or tip)? n/a.Please indicate the affected/broken part in the image below.N/a.Please provide the account contact information (name and email address) to who we can send the closure letter once the investigation is complete.N/a.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2020 and fibrin sealant preparation device was used.During the procedure, the handle broke, and only some of one side of the biologic came out.No adverse patient consequences were reported.Additional information was requested.

• 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: 10624086
• Report Number: 2210968-2020-07603
• Device Sequence Number: 16438805
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/24/2020

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): Initial
• Initial Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 10/02/2020
• Patient Sequence Number: 1