• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC ENSEAL X1 ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ETHICON ENDO-SURGERY, LLC ENSEAL X1 ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES) Back to Search Results
Model Number NSLX120L
Device Problem Failure to Cut (2587)
Patient Problem Insufficient Information (4580)
Event Date 10/15/2020
Event Type  malfunction  
Event Description
Enseal x1 large jaw tissue sealer will not cut.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameENSEAL X1
Type of DeviceELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)
Manufacturer (Section D)
ETHICON ENDO-SURGERY, LLC
475 calle c
guaynabo PR 00969
MDR Report Key10791977
MDR Text Key214801591
Report Number10791977
Device Sequence Number1
Product Code HGI
UDI-Device Identifier10705036015024
UDI-Public(01)10705036015024(17)220228(10)U93L1M
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/21/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNSLX120L
Device Catalogue NumberNSLX120L
Device Lot NumberU93L1M
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/21/2020
Event Location Hospital
Date Report to Manufacturer11/05/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-