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

Model Number	0846
Medical Device Problem Code	Arcing of Electrodes (2289)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a chole procedure the surgeon expressed that her bovie wasn¿t working, she felt like she was not was getting enough power, coag effect, so power level was adjusted from 3 to 5, and then hemostasis was acceptable remainder of case.All was working well at power level 5 without bleeding issues.Arching events with monopolar.Switched mega soft pad to sticky pad and that resolved the issue.Viodv generator for robotic procedures were used.There was a pink pad between the megasoft and the patient.The case was completed with no patient consequences.
Additional Manufacturer Narrative
(b)(4).Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.The device history records were reviewed and certed by external manufacturing that the manufacturing criteria were met prior to the release of the equipment.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product is received at a later date, the investigation will be updated as applicable.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: MEGASOFT UNIVERSAL DUAL
• Common Device Name: MEGA SOFT UNIVERSAL DUAL
• 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 ; * ; 329348013
• MDR Report Key: 15300472
• Report Number: 1721194-2022-00074
• Device Sequence Number: 7307759
• Product Code: GEI
• UDI-Device Identifier: 10614559104248
• UDI-Public: 10614559104248
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K133726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/26/2022

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: 0846
• Device Catalogue Number: 0846
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2022
• Initial Report FDA Received Date: 08/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown