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

Model Number	RS271A30
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Padded pt with cautery ground on rt flank for hot snare polypectomy.Upon use of snare, it didn't cauterized the polyp and ended up doing cold snare on pt.Checked all connections and pressed the ground pad firmly on pt's back but still unable to do cauterization as intended to do.Right flank is dry and no hair present upon applying the pad.Once the pad is removed, site is clear, dry and intact and the pad is noted not to be as sticky as had been in the past even if you fold it to stick both sticky sides together, it does not stick on each other and easily snap off.Fda safety report id # (b)(4).
Event or Problem Description
Additional information received from a reporter on 5/24/2022 for a report #(b)(4) to change the manufacturer.Leonhard lang (b)(4).

• Brand Name: MEGADYNE NEUTRAL ELECTRODES
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; innsbruck, at
• MDR Report Key: 14257480
• Report Number: MW5109443
• Device Sequence Number: 5137870
• Product Code: GEI
• UDI-Device Identifier: 19005531507774
• UDI-Public: (01)19005531507774
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2022

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 Expiration Date: 01/13/2025
• Device Model Number: RS271A30
• Device Catalogue Number: REF 0855C
• Device Lot Number: 220113-2401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/29/2022
• Supplement Report FDA Received Date: 05/24/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown