MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. SMOKE EVACUATOR RF SENSOR; MEGADYNE¿ RF SENSOR

Model Number 2255J

Device Problem Self-Activation or Keying (1557)

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

Event Date 06/28/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.No lot or batch number was provided therefore a device history could not be done.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: what was the set up? was the smoke evacuator powered on before the generator was powered on? was the rf sensor plugged into the mese1 and the generator and mese1 was already powered up?.

Event Description

It was reported that during an unknown procedure, the smoke evacuator activated when the rf sensor was connected.There was no problem to the harmonic device when the rf sensor was not connected.Gen04 was used.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.

Manufacturer Narrative

(b)(4).Date sent: 7/27/2021.Additional information was requested, and the following was obtained: what was the set up? no further information will be available.Was the smoke evacuator powered on before the generator was powered on? no further information will be available.Was the rf sensor plugged into the mese1 and the generator and mese1 was already powered up? no further information will be available.

• Brand Name: SMOKE EVACUATOR RF SENSOR
• Type of Device: MEGADYNE¿ RF SENSOR
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 12100316
• MDR Text Key: 259425938
• Report Number: 1721194-2021-00056
• Device Sequence Number: 1
• Product Code: FYD
• UDI-Device Identifier: 10614559104644
• UDI-Public: 10614559104644
• Combination Product (y/n): N
• PMA/PMN Number: K200250
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/27/2021

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 Model Number: 2255J
• Device Catalogue Number: 2255J
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/27/2021
• Initial Date FDA Received: 07/01/2021
• Supplement Dates Manufacturer Received: 07/04/2021
• Supplement Dates FDA Received: 07/27/2021
• Patient Sequence Number: 1