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

Model Number	VSTL45
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2021
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.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.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 robotic assisted partial nephrectomy procedure on (b)(6) 2021 and a fibrin sealant preparation device was used after tumor removal during defect closure.The white spray tip was removed prior to use so the product could be dripped in multiple locations.After being moved to use the last amount of product on the hilum of the kidney, it was noticed that the orange rubber o-ring had broken off.It was quickly grabbed and removed along with the empty device.The procedure was completed successfully with a three-minute delay.The broken o-ring was removed successfully without the need of additional intervention.There were no adverse consequences for the patient.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 5/28/2021.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 6/14/2021.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 5/25/2021.Additional information was requested, and the following was obtained: 1.What is the lot number? the lot # is 5114464.2.Were there any unexpected outcomes or complications as a result of the prolonged surgery time? no, there was a slight delay as the surgeon found and removed the broken o-ring, but no impact to the patient nor the vistaseal product¿s efficacy.3.Are there pictures of the damaged device available? no pictures.4.Is the device available to be returned for evaluation? if so, please provide the status of the return and any available tracking information.Yes.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.
Additional Manufacturer Narrative
Product complaint # = > (b)(4) date sent to the fda: 7/15/2021 investigation summary = > one vstl45 was returned, attached to a vst10 device.No white spray tips were returned.The o-ring was returned, and it was split open on one side.There were signs of wear at the threaded connector indicating that a device was used to steer the end of the tip in the area where the o-ring sits.However, it is unknown what actually caused the o-ring to break off.There are no other signs of damage to the o-ring aside from the area that split.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.Corrected information: d7a, d9, h3, h6.

• Brand Name: VISTASEAL LAPAROSCOPIC DUAL APPLICATOR F
• Common Device Name: FIBRIN SEALANT PREPARATION DEVICE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11809323
• Report Number: 2210968-2021-04453
• Device Sequence Number: 19698172
• Product Code: MZM
• UDI-Device Identifier: 10705031462724
• UDI-Public: 10705031462724
• 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
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/06/2021

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 Expiration Date: 01/31/2024
• Device Model Number: VSTL45
• Device Catalogue Number: VSTL45
• Device Lot Number: 5114464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Initial Date Received by Manufacturer: 05/06/2021
• Supplement Date Received by Manufacturer: 05/12/2021; 05/25/2021; 05/28/2021; 07/07/2021
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 05/26/2021; 05/28/2021; 06/14/2021; 07/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1