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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. SMOKE EVACUATOR; MEGADYNE¿ SMOKE EVACUATOR
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MEGADYNE MEDICAL PRODUCTS, INC. SMOKE EVACUATOR; MEGADYNE¿ SMOKE EVACUATOR Back to Search Results
Model Number MESE1
Device Problem Difficult or Delayed Activation (2577)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/29/2021
Event Type  malfunction  
Event Description
It was reported that during an unknown procedure the unit is always suctioning and will not turn off.
 
Manufacturer Narrative
(b)(4).Date of event: unknown; captured as awareness date.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.Serial number was received and dhr is pending review.When the review is completed, a supplemental medwatch will be sent with a summary of the evaluation.Additional information was requested, and the following was obtained: was it was connected to the direct connect cable? yes.Direct connect cable was used what were the settings? open/medium flow rate/ medium run rate.Were the current sensor settings adjusted? no.The current settings were not adjusted.I think this may have been the problem.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Manufacturer Narrative
(b)(4).Date of event: unknown; captured as awareness date.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.Serial number was received and dhr is pending review.When the review is completed, a supplemental medwatch will be sent with a summary of the evaluation.Additional information was requested, and the following was obtained: was it was connected to the direct connect cable? yes.Direct connect cable was used what were the settings? open/medium flow rate/ medium run rate.Were the current sensor settings adjusted? no.The current settings were not adjusted.I think this may have been the problem.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 an unknown procedure the unit is always suctioning and will not turn off.
 
Manufacturer Narrative
(b)(4).Date sent: 12/30/2021.Investigation summary: per service manual operational and diagnostic analysis did not confirm the reported continuous activation.No further investigation will be conducted on this complaint.Additionally a noise issue was identified.The scroll pump was replaced to address the noise issue.The repair and testing of the unit was completed per the service manual, bringing the unit back to full functionality.The unit passed all functional tests and is fully operational.The device history records were reviewed and certed by external manufacturing that the manufacturing criteria were met prior to the release of the equipment.The certificate records are accessible through external manufacturing.
 
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Brand Name
SMOKE EVACUATOR
Type of Device
MEGADYNE¿ SMOKE EVACUATOR
Manufacturer (Section D)
MEGADYNE MEDICAL PRODUCTS, INC.
11506 south state street
draper UT 84020
Manufacturer (Section G)
MEGADYNE MEDICAL PRODUCTS, INC.
Manufacturer Contact
kara ditty-bovard
11506 south state street
draper, UT 84020
6107428552
MDR Report Key13001217
MDR Text Key286048683
Report Number1721194-2021-00083
Device Sequence Number1
Product Code FYD
UDI-Device Identifier10614559104545
UDI-Public10614559104545
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/30/2021
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 NumberMESE1
Device Catalogue NumberMESE1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/07/2021
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/29/2021
Initial Date FDA Received12/14/2021
Supplement Dates Manufacturer Received12/07/2021
Supplement Dates FDA Received12/30/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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