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

Model Number MESE1

Device Problem Difficult or Delayed Activation (2577)

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

Event Date 08/25/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.Did not receive a valid serial number for the product involved in this complaint.  therefore, we were unable to check manufacturing records for any related non-conformances additional information was requested, and the following was obtained: was it connected via direct connect cable? no further information will be available.Was the rf sensor used? no further information will be available.What were the settings? monopolar enseal device was connected with the mese1.Lap/flow/run time are level2.No further information will be available.How many times was this device used? no further information will be available.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that during a total laparoscopic hysterectomy, after the bipolar device which connected with force triad was used, monopolar enseal device which connected with the mese1 did not stop suctioning although the device was not used.The green lamp next to the lap button was blinking.The device was used under the lap mode and the level of flow and run time was 2.Gen11 was used.The device was restarted and used as is to complete the case.There were no adverse consequences to the patient.No further information is available.

• Brand Name: SMOKE EVACUATOR
• Type of Device: MEGADYNE¿ SMOKE EVACUATOR
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 12463772
• MDR Text Key: 280684892
• Report Number: 1721194-2021-00069
• Device Sequence Number: 1
• Product Code: FYD
• UDI-Device Identifier: 10614559104545
• UDI-Public: 10614559104545
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 08/24/2021

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: MESE1
• Device Catalogue Number: MESE1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/24/2021
• Initial Date FDA Received: 09/13/2021
• Patient Sequence Number: 1