MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. ZIP TIP SMOKE EVACUATION ELECTROCAUTERY; APPARATUS, EXHAUST, SURGICAL

Model Number 252510

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/20/2020

Event Type  malfunction  

Event Description

Upon opening the sterile packaging, it was observed that the clear smoke evacuation tubing was uncoiled/torn.Fda safety report id # (b)(4).

• Brand Name: ZIP TIP SMOKE EVACUATION ELECTROCAUTERY
• Type of Device: APPARATUS, EXHAUST, SURGICAL
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC. ; draper UT 84020
• MDR Report Key: 10718017
• MDR Text Key: 212775743
• Report Number: MW5097384
• 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: 74 YR