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: GLOBUS MEDICAL, INC. EXCELSIUS3D; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
  • 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
 

GLOBUS MEDICAL, INC. EXCELSIUS3D; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED Back to Search Results
Model Number EXCELSIUS3D
Device Problem Poor Quality Image (1408)
Patient Problem Unintended Radiation Exposure (4565)
Event Date 07/20/2022
Event Type  malfunction  
Event Description
The e3d was used to image a patient at the end of a surgery.The images were of poor quality and were unusable, causing the patient to endure unnecessary radiation.It was determined that the frame grabber did not catch like it was supposed to.Manufacturer response for imaging system, globus medical (per site reporter) we pulled logs from the device and sent them to the manufacturer for review.It was determined that the frame grabber did not catch like it was supposed to.We had a meeting with the e3d reps and were told to take a test image prior to each case to determine if the device is in a ¿good state.¿ we discussed what a good and bad test image looks like.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
EXCELSIUS3D
Type of Device
SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
Manufacturer (Section D)
GLOBUS MEDICAL, INC.
2560 general armistead ave.
valley forge business center
audubon PA 19403
MDR Report Key15612102
MDR Text Key301835053
Report Number15612102
Device Sequence Number1
Product Code JAA
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 09/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberEXCELSIUS3D
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/23/2022
Device Age2 MO
Event Location Hospital
Date Report to Manufacturer10/14/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-