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

Model Number 5DCS

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 12/15/2022

Event Type  malfunction  

Event Description

Or reports that the endopath 5mm curved scissors were not responding.Unplugged and replugged all cords and ports a second time.Replaced machine and the scissors still did not work.Unplugged and replugged all cords and ports into a new machine a second time.Replaced the endo path scissors and everything worked immediately.

• 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: 16136947
• MDR Text Key: 307074503
• Report Number: 16136947
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 5DCS
• Device Catalogue Number: 5DCS
• Device Lot Number: 906A87
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/27/2022
• Event Location: Hospital
• Date Report to Manufacturer: 01/11/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1