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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, cholangiography
Product CodeGBZ
Regulation Number 878.4200
Device Class 1

MDR Year MDR Reports MDR Events
2018 51 51
2019 12 12
2020 11 11
2021 7 7
2022 7 7
2023 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Unsealed Device Packaging 13 13
Material Separation 10 10
Break 10 10
Fluid/Blood Leak 5 5
Device Contaminated During Manufacture or Shipping 5 5
Protective Measures Problem 4 4
Material Split, Cut or Torn 4 4
Detachment of Device or Device Component 4 4
Obstruction of Flow 3 3
Flushing Problem 3 3
Entrapment of Device 3 3
Positioning Problem 3 3
Defective Device 2 2
Material Deformation 2 2
Delivered as Unsterile Product 2 2
Component Missing 2 2
Insufficient Information 2 2
Difficult to Insert 2 2
Burst Container or Vessel 2 2
Complete Blockage 2 2
Detachment Of Device Component 1 1
Crack 1 1
Disconnection 1 1
Erratic or Intermittent Display 1 1
No Display/Image 1 1
Inadequate Instructions for Healthcare Professional 1 1
Leak/Splash 1 1
Loss of or Failure to Bond 1 1
Fracture 1 1
Material Fragmentation 1 1
Structural Problem 1 1
Failure to Advance 1 1
Split 1 1
Separation Failure 1 1
Device Markings/Labelling Problem 1 1
Device Operates Differently Than Expected 1 1
Device Dislodged or Dislocated 1 1
Device Contamination with Chemical or Other Material 1 1
Gas/Air Leak 1 1
Device Slipped 1 1
Unraveled Material 1 1
Improper or Incorrect Procedure or Method 1 1
Material Perforation 1 1
Defective Component 1 1
Material Puncture/Hole 1 1
Product Quality Problem 1 1
Difficult to Remove 1 1
Appropriate Term/Code Not Available 1 1
Therapeutic or Diagnostic Output Failure 1 1
Misassembly by Users 1 1
Physical Resistance/Sticking 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Material Twisted/Bent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 45 45
No Information 10 10
No Clinical Signs, Symptoms or Conditions 10 10
No Patient Involvement 8 8
Insufficient Information 6 6
No Consequences Or Impact To Patient 5 5
Pneumothorax 4 4
Foreign Body In Patient 3 3
No Code Available 3 3
Device Embedded In Tissue or Plaque 1 1
Low Blood Pressure/ Hypotension 1 1
Failure of Implant 1 1
Inflammation 1 1
Pleural Effusion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Atrium Medical Corporation II Dec-02-2023
2 Atrium Medical Corporation II Jun-28-2022
3 Atrium Medical Corporation II Dec-06-2018
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