MAUDE Adverse Event Report: STARMED CO., LTD. PROTEUS; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Patient Problems Hemorrhage/Bleeding (1888); Hemothorax (1896); Pleural Effusion (2010); Unspecified Gastrointestinal Problem (4491)

Event Type  Injury  

Event Description

According to the literature, a retrospective study was conducted between april 2005 and august 2020 to compare outcomes of laparoscopic radiofrequency ablation (lrfa) and percutaneous radiofrequency ablation methods (prfa) in patients with hepatocellular carcinoma.A total of 381 patients underwent prfa or lrfa using a cool-tip or a non-medtronic electrode.The following complications were reported in both rfa groups: pleural effusion, hemothorax, perihepatic bleeding and bowel injury, the author did not mention any interventions used to treat these complications.The article did not specify which electrode was associated with the reported complications.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PROTEUS
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): STARMED CO., LTD.
• MDR Report Key: 17661679
• MDR Text Key: 322504060
• Report Number: MW5145104
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Report Date: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1