MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. MEGAPOWER 1000 A GENERATOR; MEGA POWER 1000 A, GENERATOR

Model Number 1000

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Unintended Electrical Shock (4018)

Patient Problems Shock (2072); Partial thickness (Second Degree) Burn (2694)

Event Date 01/05/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Investigation summary: per service manual operational and diagnostic analysis did not confirm the reported issue.No further investigation will be conducted on this complaint.The device history records were reviewed and certed by external manufacturing that the manufacturing criteria were met prior to the release of the equipment.The certificate records are accessible through external manufacturing.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: are there any photos of the burn that you could share with us in regards to the burn? if yes, please send to (b)(6).What medical intervention was used to treat the burn? (such as salve or stitches).Besides the burn, did the surgeon experience any adverse consequence due to the issue? are there any anticipated long-term effects from the burn or injury? what is the current status of the surgeon? does the surgeon believe there is there an alleged deficiency to the generator that led to surgeons burn and if so why? how tightly was the surgeon holding hemostat? was the bovie touched to the hemostat above or below the surgeon¿s hand? how was the patient grounded (megasoft or sticky pad)?.

Event Description

It was reported that during a c-section procedure that while closing with the surgical tech the surgeon was shocked and burnt during the procedure.Surgeon was using a hemostat and the scrub tech was using the bovie.Surgeon felt a ¿rush¿ and then a ¿stinging¿ which caused her to drop the hemostat.After inspection it was found that she had been burned through her glove causing a small second-degree burn.Same equipment was used to complete the procedure.There were no adverse consequences for the patient.

Manufacturer Narrative

(b)(4).Date sent: 2/14/2022 h6.

Manufacturer Narrative

(b)(4).Date sent: 2/11/2022.Additional information was requested and the following was obtained: what medical intervention was used to treat the burn? (such as salve or stitches).Salve besides the burn, did the surgeon experience any adverse consequence due to the issue? no.Are there any anticipated long-term effects from the burn or injury? none.What is the current status of the surgeon? still working.Does the surgeon believe there is there an alleged deficiency to the generator that led to surgeons burn and if so why? this a procedure that it is performed on a daily basis without incident.The generator was sent out for evaluation and returned how tightly was the surgeon holding hemostat? holding the hemostats normally was the bovie touched to the hemostat above or below the surgeon¿s hand? below.How was the patient grounded (megasoft or sticky pad)? sticky pad.

• Brand Name: MEGAPOWER 1000 A GENERATOR
• Type of Device: MEGA POWER 1000 A, GENERATOR
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• Manufacturer (Section G): MEGADYNE MEDICAL PRODUCTS, INC.
• Manufacturer Contact: kara ditty-bovard ; 11506 south state street; draper, UT 84020 ; 6107428552
• MDR Report Key: 13358801
• MDR Text Key: 286873122
• Report Number: 1721194-2022-00005
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10614559103715
• UDI-Public: 10614559103715
• Combination Product (y/n): N
• PMA/PMN Number: K050579
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1000
• Device Catalogue Number: 1000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention