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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP FORCETRIAD ENERGY PLATFORM; ELECTROSURGICAL GENERATOR
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COVIDIEN LP FORCETRIAD ENERGY PLATFORM; ELECTROSURGICAL GENERATOR Back to Search Results
Catalog Number FORCETRIAD
Device Problem Failure to Obtain Sample (2533)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/08/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Date of initial report: (b)(6) 2016.To date the unit has not been received for evaluation.If the sample is received or if additional information pertinent to the incident is obtained a follow-up report will be submitted.A review of the appropriate device history records indicate rework performed on this serial number is not related to this evaluation.
 
Event Description
The customer reported that two modes activated simultaneously.No patient involvement.No further information is available at this time.
 
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Brand Name
FORCETRIAD ENERGY PLATFORM
Type of Device
ELECTROSURGICAL GENERATOR
Manufacturer (Section D)
COVIDIEN LP
5920 longbow drive
boulder CO 80301
Manufacturer Contact
matthew amaral
5920 longbow drive
boulder, CO 80301
2034926373
MDR Report Key5922589
MDR Text Key53746199
Report Number1717344-2016-00822
Device Sequence Number1
Product Code GEI
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K110268
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/01/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberFORCETRIAD
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/08/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/31/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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