MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. E-Z CLEAN BLADE 6.5IN BNS; E-Z CLEAN BLADE 6.5 INCH BNS

Model Number 0014BN

Device Problems Arcing of Electrodes (2289); Device Misassembled During Manufacturing /Shipping (2912); Human-Device Interface Problem (2949)

Patient Problems Burn(s) (1757); Scar Tissue (2060); Burn, Thermal (2530)

Event Date 10/14/2020

Event Type  Injury  

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.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: what is the severity of the burn? examples: 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? was there any change in patient care as a result of this event? what is the current patient status? what is the lot number of the device? are there any photos that you could share of the burn on the patient? what was the generator settings? was any device used to put the electrode into the pencil? is the device being held by risk management? how long into the procedure was the burn noted? how long was the procedure? what was the procedure( open or lap)? was the pencil holder being used when the clean blade was not being used by surgeons? if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that while using the cautery tip, the tip "arched" at the insulated tip burning the patient causing the surgery team to excise the burn.One device is available for return.

Manufacturer Narrative

(b)(4).Date sent: 11/30/2020.The account provided 1 photo of the device: during the evaluation of the provided photo, a hole in the blue insulation was observed.The hole is small and round exposing the metal substrate with melting around the edges and blackened in color.The hole is located down from the tip of the device.The damage may have been caused by the electrode coming in contact, with other instruments.The most likely cause is a current strayed from this damaged area, evident by the characteristic of being melted and blackened, which most likely resulted in a burn to the patient.The instructions for use for the device, instruct the user to discard damaged electrodes.Additional information was requested, and the following was obtained: what is the severity of the burn? examples: 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? was there any change in patient care as a result of this event? what is the current patient status? what is the lot number of the device? are there any photos that you could share of the burn on the patient? what was the generator settings? was any device used to put the electrode into the pencil? is the device being held by risk management? how long into the procedure was the burn noted? how long was the procedure? what was the procedure( open or lap)? was the pencil holder being used when the clean blade was not being used by surgeons? answer= at this time i have made numerous attempts for clinical data to the customer.Unfortunately, i will not be able to provide anything further.If i should receive anything from the end-user i will update you.

Manufacturer Narrative

(b)(4).Date sent: 12/14/2020.Additional information was requested, and the following was obtained: what is the severity of the burn? first degree burn.Are there any anticipated long-term effects from the burn? altered scarring from longer incision to excise burn.Was there any change in the patient care as a result of this event? new bovie tip provided.What is the current patient status? no answer.What is the lot number of the device? 450671- it came in a breast aug pack.The scrub reports it was not packaged and floating freely in the pack.Are there any photos that you could share of the burn on the patient? no answer.What was the generator settings? 45.45.Was any device used to put the electrode into the pencil? none.Is the device being held by risk management? yes.How long into the procedure was the burn noted? immediately.How long was the procedure? ~1 hour.What was the procedure( open or lap) ? breast augmentation.Was the pencil holder being used when the clean blade was not being used by surgeons? yes.The analysis team is requesting that the device be returned.Age, gender, and weight of the patient: 34 y.O.F, 118 lbs.450671 lot number was provided.This lot number is not a valid lot number.The lot was not provided; therefore, the manufacturing records could not be reviewed.

Manufacturer Narrative

(b)(4).Date sent: 2/25/2021.The product was returned to ethicon endo surgery for evaluation.Visual inspection and functional testing were conducted on the returned device.The device was not received in its original packaging.Upon visual inspection, it was noted a hole in the blue insulation.The hole is small and round exposing the metal substrate with melting around the edges and blackened in color.In addition, was noted dry body fluid on the electrode surface.Due to the condition of the device returned we were unable to investigate further packaging device matter issues.It should be noted that product failure is multifactorial.The damage may have been caused by the electrode coming in contact, with other instruments.The most likely cause is a current strayed from this damaged area, evident by the characteristic of being melted and blackened, which most likely resulted in a burn to the patient.The instructions for use for the device, instruct the user to discard damaged electrodes.As part of ethicon endo surgery quality process all devices are manufactured, inspected, and released to approved specifications.Correction on mwr-08122020-0000856620 a0206 and e1715 should have been added.

• Brand Name: E-Z CLEAN BLADE 6.5IN BNS
• Type of Device: E-Z CLEAN BLADE 6.5 INCH BNS
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 10822196
• MDR Text Key: 217318677
• Report Number: 1721194-2020-00058
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10614559101308
• UDI-Public: 10614559101308
• Combination Product (y/n): N
• PMA/PMN Number: K862221
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/19/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: 0014BN
• Device Catalogue Number: 0014BN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Initial Date Manufacturer Received: 10/19/2020
• Initial Date FDA Received: 11/11/2020
• Supplement Dates Manufacturer Received: 11/18/2020; 12/08/2020; 02/23/2021
• Supplement Dates FDA Received: 11/30/2020; 12/14/2020; 02/25/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR
• Patient Weight: 54