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

Catalog Number GCFRGD

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Fever (1858); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pleural Effusion (2010)

Event Date 10/04/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 1/5/2024 d4: batch # unk.An analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.Additional information was requested and the following was obtained: did the device staple? -yes if so, did the device deploy the whole staple line? -yes if so, were the staples the appropriate b-shape form? -yes what device was used with the reported cartridge? -psee45a.Was the device stapled on normal lung tissue or emphysematous? - normal lung tissue.

Event Description

It was reported that during a thoracoscopic right pulmonary bullectomy, the operation went smoothly.No obvious bleeding at the resection margin was found during the operation.The chest drainage was increased on the 2nd day after the operation.On october 6, re-examination of chest x-ray and chest ct showed increased hemothorax on the right side and poor patency of chest tube drainage.It was considered to have postoperative intrathoracic hemorrhage with blood clots blocking the chest tube.The patient was given intrapleural injection of urokinase and ecg monitoring.230ml bloody fluid could be extracted from the chest tube.Reexamination of blood routine showed hemoglobin concentration 74 (g/l) , which was considered to be caused by intrathoracic hemorrhage.On october 8, red blood cells 2u and fresh frozen plasma 200ml were infused.Later re-examination of chest x-ray showed decreased pleural effusion on the right side and the right chest tube was removed on (b)(6).On october 10, the patient had high fever, with the highest body temperature of 39.0, occasional chest tightness.The re-examination showed infection indicators increased.The anti-infective treatment was continued.The re-examination of chest ct suggested right intrathoracic effusion.On (october 13, the patient was given ultrasound-guided closed thoracic drainage.After the operation, reddish fluid was extracted and the chest tightness was relieved.On (b)(6), the right thoracic drainage was removed.No additional information can be provided.

• 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: 18459446
• MDR Text Key: 332251599
• Report Number: 3005075853-2024-00132
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• 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: 12/08/2023
• 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