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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP LIGASURE IMPACT; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
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COVIDIEN LP LIGASURE IMPACT; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES Back to Search Results
Model Number LF4318
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Swelling (2091); Burn, Thermal (2530)
Event Date 04/12/2018
Event Type  malfunction  
Event Description
Blister from touching skin with ligature device.Device was not being activated against skin.Skin was retracted from site while being used, but must have remained so hot afterwards that it burned skin.Doctor also mentioned that it could have been caused by the steam created with the device during activation.Device representative states they have seen documentation of this before.Manufacturer response for liagature, coviden ligature impact curved, large jaw, open (per site reporter).We will send the cautery machine and ligature applier in for evaluation.
 
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Brand Name
LIGASURE IMPACT
Type of Device
ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
Manufacturer (Section D)
COVIDIEN LP
15 hampshire street
mansfield MA 02048
MDR Report Key7498494
MDR Text Key107770928
Report Number7498494
Device Sequence Number1
Product Code GEI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 04/24/2018
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 Physician
Device Expiration Date10/03/2021
Device Model NumberLF4318
Device Catalogue NumberLF4318
Device Lot Number62780249X
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/17/2018
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/24/2018
Event Location Hospital
Date Report to Manufacturer04/24/2018
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/09/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NOT APPLICABLE.
Patient Outcome(s) Other;
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