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

Catalog Number	0037H
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.
Event or Problem Description
It was that during an open unknown procedure, the tip of the 0037h took fire.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.
Additional Manufacturer Narrative
(b)(4).Date sent: 5/3/2019.Investigation summary: received 1 each 0037h, unknown lot number.Customer reported; flame flash fire.No signs of charring/burn marks were observed on the pencil.Pencil was functionally tested and was found performing within specifications.The complaint is unconfirmed.The lot was not provided; therefore, the manufacturing records could not be reviewed.

• Brand Name: E-Z CLN PNCL BTN MOD BLD HLSTR
• Common Device Name: E-Z CLEAN PENCIL BTN MOD BLADE HOLSTER
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 8475523
• Report Number: 1721194-2019-00090
• Device Sequence Number: 11230279
• Product Code: GEI
• UDI-Device Identifier: 10614559101674
• UDI-Public: 10614559101674
• 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
• Report Date (Section B): 03/18/2019

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 Number: 0037H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2019
• Initial Date Received by Manufacturer: 03/18/2019
• Supplement Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 04/02/2019
• Supplement Report FDA Received Date: 05/03/2019
• Patient Sequence Number: 1