MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. MEGADYNE; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number	004125
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Coagulater would not fire.

• Brand Name: MEGADYNE
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 s. state st.; draper UT 84020
• MDR Report Key: 11100340
• Report Number: 11100340
• Device Sequence Number: 19066235
• Product Code: GEI
• UDI-Device Identifier: 10614559105146
• UDI-Public: (01)10614559105146
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/10/2020
• Report Date (Section F): 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 004125
• Device Catalogue Number: 004125
• Device Lot Number: 200910
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 12/31/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 12/15/2020