MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. E-Z CLEAN NEEDLE MOD 2.75IN; E-Z CLEAN NEEDLE MODIFIED 2.75 INCH

Model Number	0013M
Medical Device Problem Code	Arcing of Electrodes (2289)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2021
Type of Reportable Event	Malfunction
Additional 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 was requested, and the following was obtained: was there any burn to the patient or to the user? fortunately, patient didn't get burned.If yes for a burn what is the severity of the burn? na.First degree burns are minor burns on the first layer of skin.Second degree burns have two types: superficial partial-thickness burns injure the first and second layers of skin.Deep partial-thickness burns injure deeper skin layers.Third degree burns injure all the skin layers and tissue under the skin.Are there any anticipated long-term effects from the burn or injury? na.What medical intervention was used to treat the burn or injury? (such as salve or stitches) na.Could you please confirm if were fragments generated? fragment was not created.There is also a slight melting trace of the modified part.If yes, were they removed easily without additional intervention? na.Was there any change in the patient care as a result of this event? there was no change.What is the current patient status? no information.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 a thyroidectomy, when contacting the thyroid after tissue detachment, a spark occurs at the tip of the megadyne modified needle electrode 0013m and the bovie tip is burned and broken.There were no patient consequences.
Additional Manufacturer Narrative
(b)(4).Date sent: 3/23/2021.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 0013m device was received with the tip of the electrode charred.In addition, no damage to the insulation was noted.It should be noted that product failure is multifactorial.The most likely cause of this damage is caused by operating the electrosurgery equipment (generator) at high power settings with continual activation of the electrode for long periods or by placing the electrode tip against another instrument causing extreme heat which results in melting of the tip.As part of ethicon endo surgery¿s quality process all devices are manufactured, inspected, and released to approved specifications.The batch history records were reviewed and certified by external manufacturing that the manufacturing criteria was met prior to the release of the equipment.The certificate records are accessible through external manufacturing.

• Brand Name: E-Z CLEAN NEEDLE MOD 2.75IN
• Common Device Name: E-Z CLEAN NEEDLE MODIFIED 2.75 INCH
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 11207267
• Report Number: 1721194-2021-00004
• Device Sequence Number: 4140109
• Product Code: GEI
• UDI-Device Identifier: 10614559100134
• UDI-Public: 10614559100134
• Combination Product (Y/N): N
• PMA/510(K) Number: K081791
• 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
• Report Date (Section B): 01/03/2021

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: 0013M
• Device Catalogue Number: 0013M
• Device Lot Number: 200718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Initial Date Received by Manufacturer: 01/03/2021
• Supplement Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 01/21/2021
• Supplement Report FDA Received Date: 03/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1