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

Model Number 0855CN

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/12/2022

Event Type  Injury  

Event Description

Bovie pad was placed on patient.Patient had a polyp that needed to be snared with cautery.Applied 3 bovie pads that did not contact with patient, so bovie could not be used.This resulted in having to "cold snare" the polyp.This is an acceptable alternative, however the cold snare caused a small amount of blood loss, so a hemostasis clip was applied.If the bovie pad worked correctly, the bovie could have been used and the likelihood of a clip being used would have been lower.Fda safety report id# (b)(4).

• Brand Name: MEGADYNE ELECTROSURGICAL PATIENT RETURN ELECTRODES BOVIE PAD
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.
• MDR Report Key: 15625842
• MDR Text Key: 302013949
• Report Number: MW5112683
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2022
• 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: 2108133
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 29 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White