MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. ZIP PEN SMOKE EVACUATION CAUTERY PENCIL; APPARATUS, EXHAUST, SURGICAL

Model Number 252510

Device Problems Defective Device (2588); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 10/20/2020

Event Type  malfunction  

Event Description

Megadyne zip tip smoke evacuation cautery pencil's coagulation function did not work.Product was examined with no visible issues noted.Another product was then utilized without issue.Fda safety report id # (b)(4).

• Brand Name: ZIP PEN SMOKE EVACUATION CAUTERY PENCIL
• Type of Device: APPARATUS, EXHAUST, SURGICAL
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC. ; draper UT 74020
• MDR Report Key: 10718144
• MDR Text Key: 212784825
• Report Number: MW5097387
• Device Sequence Number: 1
• Product Code: FYD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/20/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 252510
• Device Catalogue Number: 252510
• Device Lot Number: 1806169
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/21/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 61 YR