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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. E-Z CLEAN PNCL BTN HLSTR; E-Z CLEAN PENCIL BUTTON HOLSTER
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MEGADYNE MEDICAL PRODUCTS, INC. E-Z CLEAN PNCL BTN HLSTR; E-Z CLEAN PENCIL BUTTON HOLSTER Back to Search Results
Catalog Number 0035H
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 07/26/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).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 dhr review of the reported lot number confirmed that the product was produced accomplishing quality requirements and released according to established procedures.
 
Event or Problem Description
It was reported that during a coronary artery bypass graft procedure the electrosurgical pencil activated without the buttons being pressed.The surgical team noted that the pencil activated with the cord was manipulated manually without depressing the activation buttons.The pencils were connected to a (b)(6) generator.The first two pencils they utilized in the case both had this issue.A third pencil was opened and did not have this issue.There were no patient consequences reported.
 
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Brand Name
E-Z CLEAN PNCL BTN HLSTR
Common Device Name
E-Z CLEAN PENCIL BUTTON HOLSTER
Manufacturer (Section D)
MEGADYNE MEDICAL PRODUCTS, INC.
11506 south state street
draper UT 84020
MDR Report Key8931980
Report Number1721194-2019-00114
Device Sequence Number13581506
Product Code GEI
UDI-Device Identifier10614559100493
UDI-Public10614559100493
Combination Product (Y/N)N
PMA/510(K) Number
K965054
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 08/01/2019
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 Catalogue Number0035H
Device Lot Number1803220
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/01/2019
Initial Report FDA Received Date08/26/2019
Patient Sequence Number1
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