MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC ENDOPATH; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number EPH04

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 07/08/2022

Event Type  malfunction  

Event Description

Patient came to the or for a nephrectomy.During the procedure the endopath electrosurgery probe plus ii device would not work.A new device was opened.Email has been sent to the manufacturer requesting credit, no response received yet.

• Brand Name: ENDOPATH
• Type of Device: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• MDR Report Key: 15051738
• MDR Text Key: 296148498
• Report Number: 15051738
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: EPH04
• Device Catalogue Number: EPH04
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/11/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/19/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28105 DA
• Patient Sex: Male
• Patient Weight: 92 KG