MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. PNCL 12 USE RKR HLSTR 15FT CORD; PENCIL 12 USE ROCKER HOLSTER 15 FT CORD

Catalog Number	3030HL
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
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 lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.
Event or Problem Description
It was reported that the device activated on the coag by itself.It is unknown how the procedure was completed and there were no patient consequences reported.There is no additional information.

• Brand Name: PNCL 12 USE RKR HLSTR 15FT CORD
• Common Device Name: PENCIL 12 USE ROCKER HOLSTER 15 FT CORD
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 8679134
• Report Number: 1721194-2019-00100
• Device Sequence Number: 19422932
• Product Code: GEI
• UDI-Device Identifier: 10614559102534
• UDI-Public: 10614559102534
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K050102
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/17/2019

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: 3030HL
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2019
• Initial Report FDA Received Date: 06/07/2019
• Patient Sequence Number: 1