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

Model Number	VSTL45
Medical Device Problem Code	Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # = > (b)(4).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.
Event or Problem Description
It was reported that a patient underwent a robotic hysterectomy procedure on (b)(6) 2020 and fibrin sealant dual applicator was used.There is too much memory at the distal tip of the applicator and it's difficult to visualize and grasp laparoscopically.Case was successfully completed.There were no patient complications reported.No device will be returned.Additional information was requested.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Date sent to the fda: 7/1/20.Corrected information: b1, h1 - this event no longer meets reportable malfunction criteria.

• Brand Name: VISTASEAL LAPAROSCOPIC DUAL APPLICATOR F
• 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: 10113777
• Report Number: 2210968-2020-04302
• Device Sequence Number: 2115451
• Product Code: MZM
• UDI-Device Identifier: 10705031462724
• UDI-Public: 10705031462724
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2020

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: VSTL45
• Device Catalogue Number: VSTL45
• Initial Date Received by Manufacturer: 05/13/2020
• Supplement Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 06/03/2020
• Supplement Report FDA Received Date: 07/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1