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

Model Number	0020
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On removal of supply from body through trocar, supply item was found to have shredded insulation at cautery tip.

• Brand Name: MEGADYNE
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 4545 creek rd.; cincinnati OH 45242
• MDR Report Key: 17037858
• Report Number: 17037858
• Device Sequence Number: 7030530
• Product Code: GEI
• UDI-Device Identifier: 10614559100318
• UDI-Public: (01)10614559100318(17)271130
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/01/2023
• Report Date (Section F): 05/01/2023

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: Other
• Device Model Number: 0020
• Device Catalogue Number: 0020
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/01/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/01/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/01/2023