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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP LIGASURE SYSTEM GENERATOR-INT; ELECTROSURGICAL GENERATOR
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COVIDIEN LP LIGASURE SYSTEM GENERATOR-INT; ELECTROSURGICAL GENERATOR Back to Search Results
Catalog Number LIGASURE8
Device Problem Failure to Obtain Sample (2533)
Patient Problem No Patient Involvement (2645)
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 appropriate device history records indicate rework performed on this serial number is not related to this evaluation.
 
Event Description
The customer reported that a lf1537 ligasure device activated automatically without pushing the switch when used with a ligasure 8 generator.No patient present.Malfunction occurred during testing.
 
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Brand Name
LIGASURE SYSTEM GENERATOR-INT
Type of Device
ELECTROSURGICAL GENERATOR
Manufacturer (Section D)
COVIDIEN LP
5920 longbow drive
boulder CO 80235
Manufacturer Contact
matthew amaral
5920 longbow drive
boulder, CO 80235
2034926373
MDR Report Key5912153
MDR Text Key53445001
Report Number1717344-2016-00789
Device Sequence Number1
Product Code GEI
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K043273
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 08/03/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/29/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberLIGASURE8
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/03/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/28/2006
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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