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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 Burn(s) (1757)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).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 device history records indicated that this serial number was released meeting all specifications as manufactured.
 
Event Description
The customer reported that during a laparoscopic hysterectomy a patient burn occurred while a forcetriad generator was in use with a unknown non covidien handpiece.Burn occurred on the cross sectional part of a vessel ligament.Tissue was naturally treated and no additional treatment was required.
 
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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
sharon murphy
5920 longbow drive
boulder, CO 80301
2034925267
MDR Report Key5763016
MDR Text Key48624703
Report Number1717344-2016-00545
Device Sequence Number1
Product Code GEI
Combination Product (y/n)N
Reporter Country CodeKS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other
Type of Report Initial
Report Date 06/03/2016
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 Catalogue NumberFORCETRIAD
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/03/2016
Initial Date FDA Received06/30/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/31/2008
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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