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

Model Number	VSTL45
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device not returned.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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.What is the lot number? were there any unexpected outcomes or complications as a result of the prolonged surgery time? are there pictures of the damaged device available? is the device available to be returned for evaluation? if so, please provide the status of the return and any available tracking information.
Event or Problem Description
It was reported that a patient underwent a laparoscopic hernia repair procedure on (b)(6) 2021 and a fibrin sealant preparation device was used.The scrub tech attempted to assemble the fibrin sealant preparation device and could not attach it.The surgeon attempted to attach it and broke the fibrin sealant preparation device.The surgery was delayed by 10 minutes.Another like device was used to complete the procedure.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 3/4/2021.Additional information was requested, and the following was obtained: 1.What is the lot number? unknown.2.Were there any unexpected outcomes or complications as a result of the prolonged surgery time? it added about 10 minutes to the procedure.There were no patient consequences.3.Are there pictures of the damaged device available? no.4.Is the device available to be returned for evaluation? if so, please provide the status of the return and any available tracking information.It is available to return, but hasn't been boxed up yet.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 F
• Common Device Name: FIBRIN SEALANT PREPARATION DEVICE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08876
• MDR Report Key: 11276861
• Report Number: 2210968-2021-01039
• Device Sequence Number: 4108016
• Product Code: MZM
• UDI-Device Identifier: 10705031462724
• UDI-Public: 10705031462724
• Combination Product (Y/N): Y
• 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,Followup
• Report Date (Section B): 01/21/2021

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: VSTL45
• Device Catalogue Number: VSTL45
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/21/2021
• Supplement Date Received by Manufacturer: 02/05/2021; 04/24/2021
• Initial Report FDA Received Date: 02/03/2021
• Supplement Report FDA Received Date: 03/04/2021; 04/29/2021
• Patient Sequence Number: 1