MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. MEGADYNE ELECTROSURGICAL PATIENT RETURN ELECTRODES; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number 0855CN

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 12/19/2022

Event Type  Injury  

Event Description

Bovie pad was placed on pt.Pt had a polyp that needed to be snared with cautery.Applied 2 bovie that did not make enough contact with pt to be able to use cautery, tried in two different generators as well.A hemostasis clip was applied because of the issues with the bovie pad and the generator.If the bovie pad worked correctly, the bovie could have been used and the likelihood of a clip being used would have been much lower.

• Brand Name: MEGADYNE ELECTROSURGICAL PATIENT RETURN ELECTRODES
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.
• MDR Report Key: 16272071
• MDR Text Key: 308582408
• Report Number: MW5114569
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• 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: 12/20/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0855CN
• Device Catalogue Number: 0855CN
• Device Lot Number: 2108136
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BOVIE GENERATOR
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 24 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White