MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. MEGASOFT; MEGA SOFT

Model Number	0830
Medical Device Problem Codes	Arcing of Electrodes (2289); Material Integrity Problem (2978); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.The lot/batch/serial number was not provided; therefore, a manufacturing record evaluation could not be performed.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that, during an unknown procedure, the output power of the electric knife was weak, and increased the output level.Then the cord of the device got on fire and the tip of the return electrode melted.Another device was used to complete the case.There were no adverse consequences for the patient.No further information is available.
Additional Manufacturer Narrative
(b)(4).Date sent: 3/19/2021.The product was returned to ethicon endo surgery for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the 0830 device was returned with burn marks at the connector area.In addition, the pigtail was attached to m2k07.Upon visual inspection to the pigtail it was observed that the internal wires of the cable were charred and burnt and was separated from the cable connector, which was also burnt, and charring observed.It should be noted that product failure is multifactorial.The most likely cause of the event is ignition occurred from the damaged pigtail cable and spread to the drape and left black charring stains on the corner of the pad.Also, the cable and pad should be inspected prior to use for damage.Defects or misapplication should be checked prior to increasing power output.Please reference the instruction for use for more information.As part of ethicon endo surgery¿s quality process all devices are manufactured, inspected, and released to approved specifications.The serial number provided is (b)(6).The pad is expired as of 2020-06.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.
Additional Manufacturer Narrative
(b)(4).Date sent: 3/11/2021.Photo analysis: the pad was not returned for evaluation and the serial number information was not provided.However, a photo was provided.During review of the photo, it indicates the ignition appeared to start near the distal end of the m2k-07.The internal wires of the cable were charred and burnt and were separated from the cable connector, which was also burnt, and the charring observed.The most likely cause of the event is ignition occurred from the damaged m2k-07 cable and spread to the drape and left black charring stains on the corner of the pad.Also, the cable and pad should be inspected prior to use for damage.Defects or misapplications should be checked prior to increasing power output.Additional information provided: the procedure was an orthopedics surgery.

• Brand Name: MEGASOFT
• Common Device Name: MEGA SOFT
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 11108426
• Report Number: 1721194-2021-00001
• Device Sequence Number: 19844086
• Product Code: GEI
• UDI-Device Identifier: 10614559101797
• UDI-Public: 10614559101797
• Combination Product (Y/N): N
• PMA/510(K) Number: K021077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/10/2020

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 Expiration Date: 06/01/2020
• Device Model Number: 0830
• Device Catalogue Number: 0830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2021
• Initial Date Received by Manufacturer: 12/10/2020
• Supplement Date Received by Manufacturer: 02/19/2021; 03/17/2021
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 03/11/2021; 03/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1