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TPLC - Total Product Life Cycle
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Device endoscopic ultrasound system, gastroenterology-urology
Definition To provide ultrasonic visualization of body cavities that can be accessed by endoscope. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Product CodeODG
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ENDOSOUND, INC
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
MICRO-TECH(NANJING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PENTAX OF AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 2
SONOSCAPE MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 96 96
2020 445 445
2021 1234 1234
2022 1832 1832
2023 2078 2078
2024 502 502

Device Problems MDRs with this Device Problem Events in those MDRs
Peeled/Delaminated 1126 1126
Break 786 786
Microbial Contamination of Device 562 562
Fluid/Blood Leak 523 523
Failure to Clean Adequately 510 510
Material Split, Cut or Torn 389 389
Obstruction of Flow 312 312
Material Separation 260 260
No Display/Image 229 229
Device Reprocessing Problem 203 203
Crack 196 196
Contamination 162 162
Detachment of Device or Device Component 156 156
Adverse Event Without Identified Device or Use Problem 140 140
Erratic or Intermittent Display 127 127
Component Missing 114 114
Optical Obstruction 104 104
Material Puncture/Hole 95 95
Mechanical Problem 83 83
Scratched Material 81 81
Device Contamination with Chemical or Other Material 79 79
Contamination /Decontamination Problem 72 72
Poor Quality Image 62 62
Leak/Splash 60 60
Unintended Movement 57 57
Optical Distortion 53 53
Loose or Intermittent Connection 40 40
Material Integrity Problem 33 33
Material Deformation 32 32
Defective Component 31 31
Partial Blockage 27 27
Dent in Material 22 22
Separation Problem 22 22
Failure to Align 21 21
Display or Visual Feedback Problem 21 21
Loss of or Failure to Bond 18 18
Defective Device 16 16
Physical Resistance/Sticking 15 15
Material Fragmentation 15 15
Material Perforation 13 13
Output Problem 13 13
Failure to Disconnect 13 13
Deformation Due to Compressive Stress 12 12
Use of Device Problem 12 12
Pitted 12 12
Complete Blockage 12 12
Degraded 12 12
Fracture 11 11
Image Display Error/Artifact 11 11
Inflation Problem 10 10
Material Twisted/Bent 10 10
Device Handling Problem 9 9
Corroded 9 9
Device Contamination with Body Fluid 8 8
Appropriate Term/Code Not Available 8 8
Difficult to Open or Close 7 7
Residue After Decontamination 7 7
Difficult to Remove 7 7
Collapse 7 7
Communication or Transmission Problem 6 6
Material Protrusion/Extrusion 5 5
Insufficient Information 5 5
Optical Problem 5 5
Electrical /Electronic Property Problem 5 5
Difficult to Insert 5 5
Material Too Rigid or Stiff 5 5
Device Damaged Prior to Use 4 4
Restricted Flow rate 4 4
Material Discolored 4 4
Failure to Eject 4 4
Mechanical Jam 4 4
Device Damaged by Another Device 4 4
Gas/Air Leak 4 4
Connection Problem 3 3
No Flow 3 3
Disconnection 3 3
Material Frayed 3 3
Image Orientation Incorrect 3 3
Particulates 3 3
Product Quality Problem 3 3
Decrease in Pressure 3 3
No Device Output 2 2
Material Rupture 2 2
Stretched 2 2
Unstable 2 2
Tear, Rip or Hole in Device Packaging 2 2
Insufficient Flow or Under Infusion 2 2
Improper or Incorrect Procedure or Method 2 2
Material Disintegration 2 2
Biofilm coating in Device 2 2
Positioning Failure 2 2
Failure to Capture 2 2
Suction Failure 2 2
Device Contaminated at the User Facility 2 2
Positioning Problem 2 2
Pressure Problem 2 2
Activation, Positioning or Separation Problem 2 2
Component or Accessory Incompatibility 2 2
Separation Failure 2 2
Infusion or Flow Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5371 5371
No Consequences Or Impact To Patient 285 285
No Patient Involvement 248 248
No Known Impact Or Consequence To Patient 122 122
Insufficient Information 69 69
Hemorrhage/Bleeding 60 60
Perforation 37 37
Pancreatitis 26 26
Unspecified Hepatic or Biliary Problem 17 17
Peritonitis 15 15
Unspecified Infection 11 11
Pain 10 10
Injury 9 9
Internal Organ Perforation 8 8
Fever 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Unspecified Gastrointestinal Problem 6 6
Thrombocytopenia 6 6
Foreign Body In Patient 6 6
Inflammation 5 5
Abdominal Pain 5 5
Abscess 5 5
Septic Shock 5 5
Sepsis 4 4
Obstruction/Occlusion 4 4
Biliary Cirrhosis 4 4
Bowel Perforation 4 4
Unspecified Tissue Injury 4 4
Pseudoaneurysm 3 3
Bacterial Infection 3 3
Failure of Implant 3 3
Hypoxia 2 2
Fistula 2 2
Death 2 2
Pulmonary Emphysema 2 2
Apnea 2 2
Aspiration/Inhalation 2 2
Respiratory Failure 2 2
Laceration(s) of Esophagus 2 2
Shock 2 2
Thrombosis/Thrombus 2 2
Gastrointestinal Hemorrhage 2 2
Muscle Hypotonia 1 1
Drug Resistant Bacterial Infection 1 1
Aspiration Pneumonitis 1 1
No Code Available 1 1
Multiple Organ Failure 1 1
Perforation of Vessels 1 1
Rupture 1 1
Peeling 1 1
Perforation of Esophagus 1 1
Loss of consciousness 1 1
Needle Stick/Puncture 1 1
Atrial Fibrillation 1 1
Anemia 1 1
Pulmonary Embolism 1 1
Hematoma 1 1
Low Blood Pressure/ Hypotension 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Olympus Corporation of the Americas II Nov-27-2020
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