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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, INC. LIGAMAX 5; CLIP, IMPLANTABLE
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ETHICON ENDO-SURGERY, INC. LIGAMAX 5; CLIP, IMPLANTABLE Back to Search Results
Model Number EL5ML
Device Problem Misfire (2532)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/07/2020
Event Type  Injury  
Event Description
Misfire of the laparoscopic clip applier resulting in tear/bleeding from the dilated vein - subsequently the stapler would not fire again, unable to easily control vein bleeding, so packed with sponge and converted to an open procedure.The clip applier misfired with inadequate closure of the clip and disruption of the vein wall.Attempts were made to place a new clip but no clip would load into the jaws of the clip applier.Attempts were made to release the clip applier handle and tried one more time.Again, no clip was deployed into the jaws and this the jaws relinked to reopen.The site was suctioned to clear the field and locate the view, while a new clip applier was retrieved.Decision was to forego another clip placement and covert to open procedure.The patient transferred to pacu in stable condition.
 
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Brand Name
LIGAMAX 5
Type of Device
CLIP, IMPLANTABLE
Manufacturer (Section D)
ETHICON ENDO-SURGERY, INC.
4545 creek rd
cincinnati OH 45242
MDR Report Key10008815
MDR Text Key189328869
Report Number10008815
Device Sequence Number1
Product Code FZP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 04/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberEL5ML
Device Catalogue NumberEL5ML
Device Lot NumberP00019P67
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/22/2020
Event Location Hospital
Date Report to Manufacturer04/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other; Required Intervention;
Patient Age8760 DA
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