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U.S. Department of Health and Human Services

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
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
ENDOSOUND, INC
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
  SUBSTANTIALLY EQUIVALENT 1
MICRO-TECH (NANJING) CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
MICRO-TECH(NANJING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PENTAX MEDICAL COMPANY
  SUBSTANTIALLY EQUIVALENT 2
PENTAX OF AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 6
SONOSCAPE MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES ENDOSCOPY GROUP, INC. (US ENDOSCOPY)
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 1 1
2015 11 11
2016 50 50
2017 82 82
2018 66 66
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 789 789
Microbial Contamination of Device 683 683
Fluid/Blood Leak 523 523
Failure to Clean Adequately 510 510
Material Split, Cut or Torn 389 389
Obstruction of Flow 313 313
Material Separation 262 262
No Display/Image 229 229
Device Reprocessing Problem 208 208
Crack 196 196
Adverse Event Without Identified Device or Use Problem 165 165
Contamination 162 162
Detachment of Device or Device Component 161 161
Erratic or Intermittent Display 127 127
Component Missing 114 114
Optical Obstruction 104 104
Material Puncture/Hole 97 97
Contamination /Decontamination Problem 93 93
Mechanical Problem 85 85
Device Contamination with Chemical or Other Material 82 82
Scratched Material 81 81
Poor Quality Image 62 62
Leak/Splash 61 61
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
Material Perforation 15 15
Physical Resistance/Sticking 15 15
Material Fragmentation 15 15
Output Problem 13 13
Failure to Disconnect 13 13
Deformation Due to Compressive Stress 12 12
Complete Blockage 12 12
Degraded 12 12
Pitted 12 12
Use of Device Problem 12 12
Image Display Error/Artifact 11 11
Fracture 11 11
Insufficient Information 11 11
Material Twisted/Bent 10 10
Inflation Problem 10 10
Corroded 9 9
Appropriate Term/Code Not Available 9 9
Device Handling Problem 9 9
Device Contamination with Body Fluid 8 8
Residue After Decontamination 7 7
Difficult to Open or Close 7 7
Collapse 7 7
Difficult to Remove 7 7
Communication or Transmission Problem 6 6
Device Damaged by Another Device 5 5
Optical Problem 5 5
Material Protrusion/Extrusion 5 5
Material Too Rigid or Stiff 5 5
Material Discolored 5 5
Difficult to Insert 5 5
Electrical /Electronic Property Problem 5 5
Restricted Flow rate 4 4
Overheating of Device 4 4
Mechanical Jam 4 4
Gas/Air Leak 4 4
Temperature Problem 4 4
Failure to Eject 4 4
Device Damaged Prior to Use 4 4
Connection Problem 3 3
Activation, Positioning or Separation Problem 3 3
No Flow 3 3
Particulates 3 3
Decrease in Pressure 3 3
Product Quality Problem 3 3
Image Orientation Incorrect 3 3
Material Frayed 3 3
Disconnection 3 3
Detachment Of Device Component 3 3
Failure to Capture 2 2
Material Disintegration 2 2
Positioning Failure 2 2
Biofilm coating in Device 2 2
Excess Flow or Over-Infusion 2 2
Material Rupture 2 2
Stretched 2 2
Unstable 2 2
Improper or Incorrect Procedure or Method 2 2
Insufficient Flow or Under Infusion 2 2
No Device Output 2 2
Optical Discoloration 2 2
Positioning Problem 2 2
Pressure Problem 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 311 311
No Patient Involvement 272 272
No Known Impact Or Consequence To Patient 231 231
Insufficient Information 69 69
Hemorrhage/Bleeding 60 60
Perforation 46 46
Pancreatitis 26 26
Unspecified Hepatic or Biliary Problem 17 17
Injury 17 17
Unspecified Infection 15 15
Peritonitis 15 15
Pain 10 10
Internal Organ Perforation 8 8
Fever 8 8
Bacterial Infection 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Inflammation 7 7
Abdominal Pain 6 6
Unspecified Gastrointestinal Problem 6 6
Foreign Body In Patient 6 6
Thrombocytopenia 6 6
No Code Available 5 5
Abscess 5 5
Sepsis 5 5
Septic Shock 5 5
Biliary Cirrhosis 4 4
Burn(s) 4 4
Bowel Perforation 4 4
Fungal Infection 4 4
Obstruction/Occlusion 4 4
Unspecified Tissue Injury 4 4
Pseudoaneurysm 3 3
Device Embedded In Tissue or Plaque 3 3
Laceration(s) of Esophagus 3 3
Failure of Implant 3 3
Hypoxia 2 2
Shock 2 2
Abrasion 2 2
Fistula 2 2
Hematoma 2 2
Apnea 2 2
Aspiration/Inhalation 2 2
Death 2 2
Pulmonary Emphysema 2 2
Thrombosis/Thrombus 2 2
Needle Stick/Puncture 2 2
Respiratory Failure 2 2
Gastrointestinal Hemorrhage 2 2
Muscle Hypotonia 1 1
Drug Resistant Bacterial Infection 1 1
Burn, Thermal 1 1
Rupture 1 1
Aspiration Pneumonitis 1 1
Multiple Organ Failure 1 1
No Information 1 1
Atrial Fibrillation 1 1
Low Blood Pressure/ Hypotension 1 1
Anemia 1 1
Cyst(s) 1 1
Perforation of Vessels 1 1
Perforation of Esophagus 1 1
Loss of consciousness 1 1
Pulmonary Embolism 1 1
Laceration(s) 1 1
Peeling 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Micro-Tech (Nanjing) Co., Ltd. II May-15-2018
2 Olympus Corporation of the Americas II Nov-27-2020
3 Olympus Corporation of the Americas II Sep-28-2015
4 Pentax Medical Company II Jul-23-2016
5 Pentax of America Inc II Aug-23-2017
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