Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. GI4000 ELECTRO SURGERY UNIT; ELECTROSURGICAL UNIT
  • 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
 

UNITED STATES ENDOSCOPY GROUP, INC. GI4000 ELECTRO SURGERY UNIT; ELECTROSURGICAL UNIT Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 03/15/2024
Event Type  malfunction  
Manufacturer Narrative
The gi4000 electro surgery unit subject of the reported event is being returned to the manufacturer for evaluation.Investigation of this event is currently in process.A follow-up report will be submitted when additional information becomes available.
 
Event Description
The user facility reported that during a patient procedure, user facility personnel were utilizing the argon plasma coagulation on the gi4000 electro surgery unit and the display screen that shows the endoscope image "blacked out".The patient procedure was subsequently cancelled.No report of injury.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
GI4000 ELECTRO SURGERY UNIT
Type of Device
ELECTROSURGICAL UNIT
Manufacturer (Section D)
UNITED STATES ENDOSCOPY GROUP, INC.
5976 heisley road
mentor OH 44060
Manufacturer (Section G)
UNITED STATES ENDOSCOPY GROUP, INC.
5976 heisley road
mentor OH 44060
Manufacturer Contact
coletta cohara
5976 heisley road
mentor, OH 44060
4403586251
MDR Report Key19097044
MDR Text Key340810316
Report Number1528319-2024-00031
Device Sequence Number1
Product Code GEI
UDI-Device Identifier00724995180256
UDI-Public00724995180256
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/12/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/15/2024
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-