MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. MEGASOFT STD CONN CABLE 2.4M; MEGA SOFT STANDARD CABLE 2.4M (8-0")

Model Number M2K01

Device Problem Arcing of Electrodes (2289)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/28/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 lot or batch number was provided therefore a device history could not be done.Additional information received: account has had megasoft for more than 4 years.While the surgeon was skeletonizing the ima a debacey with a ratek in it was being used to help with skeletonization.Bovie had a 60 degree bend.Electrical current arced to the ratek/debakey.Ratek was dry.Ratek singed.Ratek was about 2 inches away from the active bovie tip.Bovie tip was megadyne tip ¿ bovie tip status is unknown at this time.Surgeon noticed arcing throughout the procedure.Settings on generator on 30/30.They did not keep the heating pad in place (is that different than the bair hugger used to keep the patient warm?).According to emily the stacking order was: megasoft pad.Or table cover/sheet.Stryker underbody warmer.Draw sheet.Patient.A monopolar bovie pencil (megadyne) was being used in a recent cardiovascular case and the electrical energy jumped (arced) which slightly burned a raytec sponge in the chest cavity.Surgeon said bovie pencil seemed erratic most of the case so she decided to replace it which resolved the issue.Clinical engineering seems concerned that the megasoft pad was the cause of this arcing.Discussed power setting and how that effects the procedure.Discussed the path of electricity from the pad, patient, and table.Went over report from e.Boggs and ways to improve the procedure with the devices in the future.

Event Description

It was reported by that while the surgeon was performing a cabg with a megadome electro surgical and mega soft electrode.The ess pencil to the deboki set a piece of the gauze on fire.The was no patient consequences.

Manufacturer Narrative

(b)(4) date sent: 4/13/2022.Please see mw#(b)(4) attached.

Manufacturer Narrative

(b)(4).Date sent: 4/4/2022.Investigation summary: the product was returned to ethicon endo surgery for evaluation.Visual inspection and functional testing were conducted on the returned device.The cable was returned with no apparent damage.The cable was functionally tested with a multimeter and meets the specification, no abnormalities were observed.There was no evidence of flame flash fire as reported.The event described could not be confirmed as the device was returned without detectable damage.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.As part of ethicon endo surgery quality process all devices are manufactured, inspected, and released to approved specifications.

• Brand Name: MEGASOFT STD CONN CABLE 2.4M
• Type of Device: MEGA SOFT STANDARD CABLE 2.4M (8-0")
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• Manufacturer (Section G): MEGADYNE MEDICAL PRODUCTS, INC.
• Manufacturer Contact: orla o'mahony ; 11506 south state street; draper, UT 84020
• MDR Report Key: 13965103
• MDR Text Key: 289887351
• Report Number: 1721194-2022-00019
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10614559105177
• UDI-Public: 10614559105177
• Combination Product (y/n): N
• PMA/PMN Number: K133726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/13/2022

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
• Device Operator: Health Professional
• Device Model Number: M2K01
• Device Catalogue Number: M2K01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/15/2022
• Initial Date FDA Received: 03/31/2022
• Supplement Dates Manufacturer Received: 04/01/2022; 04/05/2022
• Supplement Dates FDA Received: 04/04/2022; 04/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Male