MAUDE Adverse Event Report: ETHICON INC. SURGICEL SNOW 4INX4IN(10.2CMX10.2CM); AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED

Model Number 2083

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint #
=
> (b)(4).Component code: g07002 - no device problem found.Additional information was requested, and the following was obtained: what is the lot number? unknown.This was used in sept 2022.¿ what date was the suspected undissolved surgicel snow found? on the reported date, (b)(6), 2023.Investigation summary: the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample revealed that it was received with some pieces that appear to be small pieces of tissue as ethicon perspective we cannot conclude the root cause of the issue reported.The manufacturing records could not be reviewed as the batch/lot number is unknown.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.

Event Description

It was reported that a patient underwent a tcar procedure on (b)(6) 2022 and absorbable hemostat was used.As the surgeon was dissecting to the previous arteriotomy, he found several pieces of what he assumed was undissolved surgicel snow.His normal practice is to place a few strips of snow on the arteriotomy prior to closing the tissue over the artery.He noted that it did not create any issues and had no bearing on the clinical issue that required the reoperation.The procedure was completed successfully with no patient consequences.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: SURGICEL SNOW 4INX4IN(10.2CMX10.2CM)
• Type of Device: AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16439919
• MDR Text Key: 310245328
• Report Number: 2210968-2023-01345
• Device Sequence Number: 1
• Product Code: LMG
• UDI-Device Identifier: 10705031063600
• UDI-Public: 10705031063600
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N12159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/09/2023

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
• Device Operator: Health Professional
• Device Model Number: 2083
• Device Catalogue Number: 2083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/02/2023
• Initial Date FDA Received: 02/24/2023
• Supplement Dates Manufacturer Received: 03/07/2023
• Supplement Dates FDA Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1