MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. E-Z CLEAN L-HOOK LAP 33CM; E-Z CLEAN L-HOOK LAP 33 CM

Model Number	0020
Medical Device Problem Codes	Arcing of Electrodes (2289); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: as the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.The lot/batch/serial number was not provided; therefore, a manufacturing record evaluation could not be performed.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: were there any patient consequences related to this events? could you please confirm what was 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? what medical intervention was used to treat the burn or injury? (such as salve or stitches).What is the current patient status? 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 laparoscopic cholecystectomy, the megadyne laparoscopic l hook sparked and caused a small burn mark on patient's liver.The case was successfully completed.

• Brand Name: E-Z CLEAN L-HOOK LAP 33CM
• Common Device Name: E-Z CLEAN L-HOOK LAP 33 CM
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 10520710
• Report Number: 1721194-2020-00048
• Device Sequence Number: 11656447
• Product Code: GEI
• UDI-Device Identifier: 10614559100318
• UDI-Public: 10614559100318
• Combination Product (Y/N): N
• PMA/510(K) Number: K913281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/20/2020

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: 0020
• Device Catalogue Number: 0020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2020
• Initial Report FDA Received Date: 09/11/2020
• Patient Sequence Number: 1