MAUDE Adverse Event Report: Megadyne Medical Products, Inc. Mega Soft; Electrosurgical, Cutting & Coagulation & Accessories

Catalog Number	0848
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	07/09/2026
Type of Reportable Event	Serious Injury

• Brand Name: Mega Soft
• Common Device Name: Electrosurgical, Cutting & Coagulation & Accessories
• Manufacturer (Section D): Megadyne Medical Products, Inc.; 4545 creek road; cincinnati OH 45242
• Manufacturer (Section G): Megadyne Medical Products, Inc.
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; PR ; +1(303)552-6892
• MDR Report Key: 50329900
• Report Number: 1721194-2026-00036
• Device Sequence Number: 14878511
• Product Code: GEI
• UDI-Device Identifier: 10614559104859
• UDI-Public: (01)10614559104859(17)260228
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K133726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2026
• Device Catalogue Number: 0848
• Device Lot Number: GS23050502
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/15/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/15/2026
• Initial Report FDA Received Date: 08/19/2026
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/06/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2000-2023; Z-0600-2024
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown