MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. 10FT SMOKE PENCIL UCONN; RETURN ELECTRODE CABLE, DUAL PLATE

Model Number 251010J

Device Problems Flaked (1246); Difficult or Delayed Activation (2577); Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 04/08/2022

Event Type  Injury  

Event Description

It was reported that during a back procedure while lying on their side the patient experienced a burn throughout the face as a result of a fire caused by the device.The plastic extender on the device had melted and was charred.

Manufacturer Narrative

(b)(4).Batch # unk.No lot or batch number was provided therefore a device history could not be done.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: could you please confirm what is the severity of the burn? (please see degrees of burns below and choose one).First degree burns are minor burns on the first layer of skin.The skin looks dry, redness, and may be swelling; no penetration or blisters.Second degree burn looks wet or moist.The burn site appears red, blistered, and may be swollen and painful.Third degree burn the burn site looks deep, whitening or blackened and charred.What medical intervention was used to treat the burn? (such as salve or stitches).Besides the burn, did the patient 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 affected (patient or user)? could you please provide the pictures of the device?.

Manufacturer Narrative

(b)(4).Date sent: 4/27/2022.Additional information was requested, and the following was obtained: could you please confirm what is the severity of the burn? (please see degrees of burns below and choose one) o first degree burns are minor burns on the first layer of skin.The skin looks dry, redness, and may be swelling; no penetration or blisters o second degree burn looks wet or moist.The burn site appears red, blistered, and may be swollen and painful o third degree burn the burn site looks deep, whitening or blackened and charred -what medical intervention was used to treat the burn? (such as salve or stitches) -besides the burn, did the patient 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 affected (patient or user)? could you please provide the pictures of the device? answer = patient suffered 2nd & 3rd degree burns medical intervention¿ oinment to burns topically, later patient sent to burn center did patient experience other consequence - none patient - has been discharged.No term effects for patient.Additional information received: the fire started in the tip of the pencil patient was transferred to a burn unit in (b)(6) tx degree of burn was not provided to the sales rep.(b)(6) was being used at the time.Facility preformed a root cause analysis monday (b)(6).Facility biomed stated that they had checked the "device" and everything was ok with it.Facility risk manager and quality director requested assistance with fire safety.Sales rep asked if a fire safety time out was done prior to case and facility indicated it was.Rep asked what type of anesthesia was used and they stated unknown.While speaking to the or manager she was informed that they had signed a confidentiality agreement and referred her to the risk manager and the quality director.Rep stated that when she left the facility she felt as if the facility was not placing blame on our device.

• Brand Name: 10FT SMOKE PENCIL UCONN
• Type of Device: RETURN ELECTRODE CABLE, DUAL PLATE
• 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: 14205366
• MDR Text Key: 290052703
• Report Number: 1721194-2022-00031
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10614559105573
• UDI-Public: 10614559105573
• Combination Product (y/n): N
• PMA/PMN Number: K982130
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 251010J
• Device Catalogue Number: 251010J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1