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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 CORPORATION
  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
PENTAX OF AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 3
UNITED STATES ENDOSCOPY GROUP, INC. (US ENDOSCOPY)
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 66 66
2019 96 96
2020 445 445
2021 1235 1235
2022 1832 1832

Device Problems MDRs with this Device Problem Events in those MDRs
Peeled/Delaminated 830 830
Break 536 536
Microbial Contamination of Device 418 418
Fluid/Blood Leak 348 348
Material Split, Cut or Torn 246 246
Obstruction of Flow 159 159
Contamination 132 132
Failure to Clean Adequately 128 128
Crack 117 117
Device Reprocessing Problem 98 98
Adverse Event Without Identified Device or Use Problem 94 94
No Display/Image 88 88
Material Puncture/Hole 72 72
Device Contamination with Chemical or Other Material 68 68
Detachment of Device or Device Component 66 66
Contamination /Decontamination Problem 62 62
Component Missing 58 58
Mechanical Problem 54 54
Leak/Splash 51 51
Unintended Movement 48 48
Optical Distortion 47 47
Poor Quality Image 46 46
Material Separation 38 38
Scratched Material 33 33
Loose or Intermittent Connection 33 33
Defective Component 24 24
Material Integrity Problem 23 23
Dent in Material 22 22
Erratic or Intermittent Display 22 22
Display or Visual Feedback Problem 21 21
Failure to Align 21 21
Partial Blockage 21 21
Material Deformation 21 21
Defective Device 15 15
Failure to Disconnect 13 13
Physical Resistance/Sticking 13 13
Material Fragmentation 13 13
Output Problem 12 12
Inflation Problem 10 10
Device Handling Problem 9 9
Material Perforation 9 9
Appropriate Term/Code Not Available 8 8
Deformation Due to Compressive Stress 8 8
Material Twisted/Bent 8 8
Fracture 8 8
Image Display Error/Artifact 8 8
Corroded 8 8
Complete Blockage 7 7
Loss of or Failure to Bond 7 7
Use of Device Problem 7 7
Collapse 7 7
Insufficient Information 6 6
Difficult to Open or Close 6 6
Separation Problem 6 6
Degraded 5 5
Optical Obstruction 5 5
Device Contamination with Body Fluid 5 5
Optical Problem 4 4
Device Damaged by Another Device 4 4
Residue After Decontamination 4 4
Electrical /Electronic Property Problem 4 4
Restricted Flow rate 4 4
Material Frayed 3 3
Image Orientation Incorrect 3 3
Disconnection 3 3
Connection Problem 3 3
No Flow 3 3
Failure to Eject 3 3
Gas/Air Leak 3 3
Difficult to Remove 3 3
Decrease in Pressure 3 3
Product Quality Problem 2 2
Unstable 2 2
Material Discolored 2 2
Failure to Capture 2 2
Device Contaminated at the User Facility 2 2
Infusion or Flow Problem 2 2
Communication or Transmission Problem 2 2
Component or Accessory Incompatibility 2 2
No Device Output 2 2
Stretched 2 2
Positioning Problem 2 2
Insufficient Flow or Under Infusion 2 2
Device Damaged Prior to Use 2 2
Biofilm coating in Device 2 2
Electrical Power Problem 2 2
Intermittent Continuity 1 1
Grounding Malfunction 1 1
Entrapment of Device 1 1
Material Erosion 1 1
Difficult to Insert 1 1
Misassembled 1 1
Moisture Damage 1 1
Unintended System Motion 1 1
Activation Failure 1 1
Misassembly During Maintenance/Repair 1 1
Key or Button Unresponsive/not Working 1 1
Device Markings/Labelling Problem 1 1
Difficult to Advance 1 1
Chemical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2858 2858
No Consequences Or Impact To Patient 288 288
No Patient Involvement 248 248
No Known Impact Or Consequence To Patient 170 170
Insufficient Information 61 61
Hemorrhage/Bleeding 31 31
Perforation 24 24
Injury 16 16
Unspecified Hepatic or Biliary Problem 12 12
Pancreatitis 12 12
Peritonitis 10 10
Internal Organ Perforation 8 8
Unspecified Infection 6 6
Pain 5 5
Septic Shock 5 5
Inflammation 4 4
Bacterial Infection 4 4
Foreign Body In Patient 4 4
Fever 4 4
Unspecified Gastrointestinal Problem 3 3
Pseudoaneurysm 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Aspiration/Inhalation 2 2
Bowel Perforation 2 2
Thrombosis/Thrombus 2 2
Unspecified Tissue Injury 2 2
No Code Available 2 2
Biliary Cirrhosis 2 2
Death 2 2
Shock 2 2
Sepsis 2 2
Laceration(s) of Esophagus 2 2
Needle Stick/Puncture 2 2
Drug Resistant Bacterial Infection 1 1
Rupture 1 1
Perforation of Esophagus 1 1
Peeling 1 1
Abscess 1 1
Anemia 1 1
Hypoxia 1 1
Abdominal Pain 1 1
Apnea 1 1
Gastrointestinal Hemorrhage 1 1
No Information 1 1
Loss of consciousness 1 1
Hematoma 1 1
Low Blood Pressure/ Hypotension 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
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