MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. E-Z CLEAN BLADE MOD 2.5IN; E-Z CLEAN BLADE MODIFIED 2.5 INCH

Model Number	0012M
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	11/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Batch # unk.Additional information was requested and the following was obtained: what is the product code on this complaint? the tips are 0012m.What is the lot/batch number on the device? lot number 192558.What is the severity of the burn? 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.What medical intervention was used to treat the burn? (such as salve or stitches).Are there any anticipated long-term effects from the burn or injury? the treatment was excision of the burned skin edge at the time of surgery.The remaining burns healed well with simple dressings.No long term effects anticipated.The tip was megadyne 0012m, the pencil was covidien and the diathermy machine was martin.Diathermy reduced to be set at 30/30 pure cut/spray same thing happened, this time the damage to the megadyne shaft was further up.Investigation summary one each 0012m lot number 192558 was received for evaluation.During visual inspection found a burn hole at the proximal end of the blue insulation.The complaint is confirmed as use related, however without examination of the pencil involved in the event the exact user related scenario cannot be determined.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.
Event or Problem Description
It was reported that during an unknown procedure, there was a surgical burn to patients using megadyne insulated tips in conjunction with covidien handpiece.No further details were provided.
Additional Manufacturer Narrative
(b)(4).Date sent: (b)(6) 2020.Investigation summary one each 0012m lot number 192558 was received for evaluation.During visual inspection found a burn hole and melted insulation material at the proximal end of the blue insulation.The most likely cause is tissue and fluid buildup which allowed or forced the materials into the nose of the pencil where the electrode is inserted.Such conditions favor initiation of an electrical discharge which can result in thermal damage to surrounding tissue.The complaint is confirmed as use related.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.

• Brand Name: E-Z CLEAN BLADE MOD 2.5IN
• Common Device Name: E-Z CLEAN BLADE MODIFIED 2.5 INCH
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 9769893
• Report Number: 1721194-2020-00024
• Device Sequence Number: 3069155
• Product Code: GEI
• UDI-Device Identifier: 10614559100110
• UDI-Public: 10614559100110
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K081791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2020

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
• Operator of Device: Health Professional
• Device Model Number: 0012M
• Device Catalogue Number: 0012M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Initial Date Received by Manufacturer: 02/03/2020
• Supplement Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 02/28/2020
• Supplement Report FDA Received Date: 03/11/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other