MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. E-Z CLEAN PNCL BTN HLSTR; E-Z CLEAN PENCIL BUTTON HOLSTER

Catalog Number	0035H
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.
Event or Problem Description
It was reported that during an unknown procedure, the switch button did not return, and the device continued activating when the device was used for coagulation.Another device was used to complete the case.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
(b)(4).Date sent: 2/4/2019.Additional information: procedure was an aortic aneurysmectomy.During an aortic aneurysmectomy, the femoral artery was slightly damaged.Suturing was performed to stop bleeding.The amount of bleeding was unknown.Blood transfusion was not required.The patient is stable.The hospitalization is not prolonged.
Additional Manufacturer Narrative
(b)(4).Date sent: 2/15/2019.Investigation summary: received one each of 0035h, lot number 1704218.Device appeared to be very clean with no electrode included with the pencil.Connected to lab generator and both cut and coag activated and deactivated appropriately.Tested device on multimeter and cut and coag were both within specifications when activated.No issues found, complaint is not confirmed.The dhr review of the reported lot number confirmed that the product was produced accomplishing quality requirements and released according to established procedures.

• 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 Key: 8266936
• Report Number: 1721194-2019-00075
• Device Sequence Number: 1448733
• Product Code: GEI
• UDI-Device Identifier: 10614559100493
• UDI-Public: 10614559100493
• Combination Product (Y/N): N
• PMA/510(K) Number: K965054
• 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,Followup
• Report Date (Section B): 01/07/2019

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 Expiration Date: 03/31/2023
• Device Catalogue Number: 0035H
• Device Lot Number: 1704218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2019
• Initial Date Received by Manufacturer: 01/07/2019
• Supplement Date Received by Manufacturer: 01/07/2019; 01/07/2019
• Initial Report FDA Received Date: 01/22/2019
• Supplement Report FDA Received Date: 02/04/2019; 02/15/2019
• Patient Sequence Number: 1