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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EMPOWER H35; SURGICAL LASER
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EMPOWER H35; SURGICAL LASER Back to Search Results
Model Number PVMS00052
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 03/26/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The problem could be traced to component failure.We are unaware about operator injury.We are waiting for additional information from the distributor.
 
Event or Problem Description
The laser system had a failure that did not allow to use it properly.No adverse effects to patient were reported.
 
Additional Manufacturer Narrative
The problem could be traced to a component failure.The complaint has been solved and closed by the distributor without providing any information to the manufacturer.We are unaware about operator injury.
 
Event or Problem Description
The laser system had a failure that did not allow to use it properly.No adverse effects to patient were reported.
 
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Brand Name
EMPOWER H35
Common Device Name
SURGICAL LASER
MDR Report Key11752117
Report Number3004378299-2021-00069
Device Sequence Number19620124
Product Code GEX
UDI-Device Identifier08033945938185
UDI-Public08033945938185
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K180426
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Y
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other
Remedial Action Inspection
Type of Report Initial,Followup
Report Date (Section B) 10/29/2021
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
Operator of Device No Information
Device Model NumberPVMS00052
Device Catalogue NumberEMP-H35
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 03/30/2021
Supplement Date Received by Manufacturer03/30/2021
Initial Report FDA Received Date04/30/2021
Supplement Report FDA Received Date10/29/2021
Was Device Evaluated by Manufacturer? (Y/N) No
Date Device Manufactured09/28/2018
Is the Device Labeled for Single Use? (Y/N) No
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Unknown
Patient Sequence Number1
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