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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ENDO SURGERYLIGAMAXLIGAMAX EL5ML

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ETHICON ENDO SURGERY LIGAMAX LIGAMAX EL5ML   Back to Search Results
Lot Number G4RD26
Event Date 04/02/2010
Event Type  Malfunction  
Event Description

After second or third clip artery was clipped and device would not release from pt. (b) (6).

 
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Brand NameLIGAMAX
Type of DeviceLIGAMAX EL5ML
Manufacturer (Section F)
ETHICON ENDO SURGERY
cincinnati OH
Manufacturer (Section D)
ETHICON ENDO SURGERY
cincinnati OH
Device Event Key1695783
MDR Report Key1656449
Event Key1574416
Report NumberMW5015488
Device Sequence Number1
Product CodeFZP
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/06/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/06/2010
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device LOT NumberG4RD26
OTHER Device ID NumberEL5ML
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?

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