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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC ENSEAL X1; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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ETHICON ENDO-SURGERY, LLC ENSEAL X1; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Model Number NSLX120L
Device Problem Product Quality Problem (1506)
Patient Problem Bowel Perforation (2668)
Event Date 06/07/2023
Event Type  malfunction  
Event Description
The patient was scheduled for a splenectomy.During the procedure the surgeon fired ligasure.The small bowel was between the handle and ligasure during firing of instrument.Subsequently, the small bowel was injured and resulted in an unplanned small bowel resection.Surgeon believes there is a design flaw.Unfortunately, the item was not saved and information including lot/serial number was not recorded and saved.
 
Event Description
The patient was scheduled for a splenectomy.During the procedure the surgeon fired ligasure.The small bowel was between the handle and ligasure during firing of instrument.Subsequently, the small bowel was injured and resulted in an unplanned small bowel resection.Surgeon believes there is a design flaw.Unfortunately, the item was not saved and information including lot/serial number was not recorded and saved.
 
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Brand Name
ENSEAL X1
Type of Device
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Manufacturer (Section D)
ETHICON ENDO-SURGERY, LLC
475 calle c
guaynabo PR 00969
MDR Report Key17572862
MDR Text Key321453273
Report Number17572862
Device Sequence Number1
Product Code GEI
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,Followup
Report Date 06/27/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberNSLX120L
Device Catalogue NumberNSLX120L
Device Lot NumberUNKNOWN
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/27/2023
Event Location Hospital
Date Report to Manufacturer08/18/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age22265 DA
Patient SexMale
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