MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. ZIP PENCIL 10FT W/0012 UCONN; ZIP PEN SMOKE EVAC PENCIL, E-Z CLEAN

Model Number	252510
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2019
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.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported that during an unknown procedure, the bovie pencil was laid on the drape and it burned a hole in it.This was near the patient's face.The tip was changed, and the procedure was continued.The bovie was laid on the drape below the patient¿s feet and it burned a hole in it as well.The patient was not burned, and the cut was set on 35 and the coag was also set on 35.
Additional Manufacturer Narrative
(b)(4).Date sent: 1/17/2020.Batch # unk.Investigation summary: 1 each 252510 lot 1806166 was received for evaluation.The zip pen was functionally tested and found to be performing within specifications.No self-activation was found during testing.The most likely cause of the complaint is heat is generated during activation and does not immediately dissipate and tip remained hot causing damage to the drape material.The complaint is confirmed as use related.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.

• Brand Name: ZIP PENCIL 10FT W/0012 UCONN
• Common Device Name: ZIP PEN SMOKE EVAC PENCIL, E-Z CLEAN
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 9470635
• Report Number: 1721194-2019-00141
• Device Sequence Number: 11272821
• Product Code: GEI
• UDI-Device Identifier: 10614559105337
• UDI-Public: 10614559105337
• Combination Product (Y/N): N
• PMA/510(K) Number: K141587
• 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,Followup
• Report Date (Section B): 11/20/2019

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 Model Number: 252510
• Device Catalogue Number: 252510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2019
• Initial Date Received by Manufacturer: 11/20/2019
• Supplement Date Received by Manufacturer: 12/20/2019
• Initial Report FDA Received Date: 12/14/2019
• Supplement Report FDA Received Date: 01/17/2020
• Patient Sequence Number: 1