MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. MEGASOFT UNIVERSAL DUAL PLUS; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	0848
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Temperature Problem (3022); Unintended Electrical Shock (4018)
Health Effect - Clinical Codes	Burn(s) (1757); Electric Shock (2554)
Date of Event	06/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent: 8/8/2023.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.No serial number was provided therefore a device history could not be done.Additional information received: on (b)(6) 2023, a little child (11 months old) was operated on.The child was lying on the megadyne pad.The surgeons have complained that the monopolar cautery device was not working.This was checked several times, although the device confirmed the contact with ¿green¿.Meanwhile, anesthetic nurse checked relaxation status on the child while touching the child's hand.She could no longer remember if she was touching the electrodes or not (probably not).Suddenly it got very hot, and she had a small burn (degree 1-2a) on the index finger but was able to continue working.The child had no burn marks, and they could complete the procedure.The megadyne pad laid flat on the mattress without contact to any metal parts of the or table.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.
Event or Problem Description
It was reported that during an unknown procedure an employee of anesthesia received a slight blow while using the monopolar hook.There were no patient consequences.
Additional Manufacturer Narrative
(b)(4).For the alert date: the correct date of aug 2.The rep did not know about it before july 10.
Additional Manufacturer Narrative
(b)(4).Date sent: 3/14/2024.

• Brand Name: MEGASOFT UNIVERSAL DUAL PLUS
• 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: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 17481459
• Report Number: 1721194-2023-00099
• Device Sequence Number: 15697113
• Product Code: GEI
• UDI-Device Identifier: 10614559104859
• UDI-Public: 10614559104859
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/14/2024

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 Catalogue Number: 0848
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/10/2023
• Supplement Date Received by Manufacturer: 08/08/2023; 03/01/2024
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 08/16/2023; 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female