MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. GST GOLD RELOAD, 45MM, 6-ROW

Catalog Number GCFRGD

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Pneumothorax (2012)

Event Date 10/14/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 1/9/2024.D4: batch # unk.An analysis of the product could not be performed since a physical sample was not received for evaluation.The lot/ batch history records were reviewed and certified by external manufacturing that the manufacturing criteria were met prior to the release of the equipment.Additional information was requested and the following was obtained: given that the patient had a functioning chest drain why was a thoracentesis performed? -noted air leak through chest drainage bottle about 4 days after the surgery.Was the air leak from the staple line? or was the air leak from another site in the pleural space? staple line.Were the staples the appropriate b-shape form? 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.

Event Description

It was reported that after a thoracoscopic left upper pulmonary bullectomy, the patient was admitted due to "chest distress for more than 1 month", and underwent thoracoscopic left upper bullae resection under general anesthesia on (b)(6) 2023.It was reported that the operation went smoothly.No obvious air leakage was found during the operation and no obvious gas escape was observed from the chest bottle on the 1st day after the operation.A large amount of gas escape was observed from the chest bottle on the 4th day after the operation.Thoracentesis was performed again to drain the gas.The patient was improved and discharged.

• Brand Name: GST GOLD RELOAD, 45MM, 6-ROW
• Type of Device: GST GOLD RELOAD
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; PR ; 3035526892
• MDR Report Key: 18475972
• MDR Text Key: 332445686
• Report Number: 3005075853-2024-00192
• Device Sequence Number: 1
• Product Code: GST
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: GCFRGD
• Device Lot Number: 309C77
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention