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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC ADVANCED ENERGY (SALIENT) AEX GENERATOR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
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MEDTRONIC ADVANCED ENERGY (SALIENT) AEX GENERATOR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES Back to Search Results
Model Number 40-405-1
Medical Device Problem Code Output above Specifications (1432)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/29/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
Information was received from a healthcare professional (hcp) regarding a generator.It was reported that the power output for cut 1-5 were falling outside of tolerance.(specifically cut 5 was at 14.9 watts) found during biomed testing.There was no patient involved.
 
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Brand Name
AEX GENERATOR
Common Device Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
Manufacturer (Section D)
MEDTRONIC ADVANCED ENERGY (SALIENT)
180 international drive
portsmouth NH 03801
MDR Report Key12208029
Report Number1226420-2021-00113
Device Sequence Number14412818
Product Code GEI
UDI-Device Identifier00643169859678
UDI-Public00643169859678
Combination Product (Y/N)N
Initial Reporter StateIN
Initial Reporter CountryUS
PMA/510(K) Number
K143175
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 07/21/2021
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 Health Professional
Device Model Number40-405-1
Device Catalogue Number40-405-1
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/29/2021
Initial Report FDA Received Date07/21/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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