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

TPLC - Total Product Life Cycle
  • 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
 

New Search show TPLC since Back to Search Results
Device gastroscope and accessories, flexible/rigid
Definition To examine or perform procedures in the stomach. 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 CodeFDS
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
AMBU A/S
  SUBSTANTIALLY EQUIVALENT 2
EVOENDO INC
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM CORPORATION
  SUBSTANTIALLY EQUIVALENT 8
FUJIFILM CORPORATON
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM HEALTHCARE AMERICAS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
HUIZHOU XZING TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
IQ ENDOSCOPES LIMITED
  SUBSTANTIALLY EQUIVALENT 1
NEPTUNE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PENTAX OF AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2019 1376 1376
2020 601 601
2021 1755 1755
2022 6216 6216
2023 9874 9874
2024 6555 6555

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Clean Adequately 9458 9458
Break 2315 2315
Poor Quality Image 2038 2038
Microbial Contamination of Device 1872 1872
Fluid/Blood Leak 1787 1787
Device Reprocessing Problem 1726 1726
Obstruction of Flow 1260 1260
Erratic or Intermittent Display 970 970
Contamination 810 810
No Display/Image 779 779
Optical Obstruction 733 733
Detachment of Device or Device Component 710 710
Adverse Event Without Identified Device or Use Problem 464 464
Device Contamination with Chemical or Other Material 455 455
Contamination /Decontamination Problem 442 442
Optical Distortion 337 337
Unintended Movement 180 180
Component Missing 131 131
Material Split, Cut or Torn 97 97
Display or Visual Feedback Problem 89 89
Loose or Intermittent Connection 88 88
Image Display Error/Artifact 78 78
Partial Blockage 70 70
Mechanical Problem 65 65
Leak/Splash 56 56
Collapse 50 50
Communication or Transmission Problem 43 43
Material Too Rigid or Stiff 35 35
Fracture 34 34
Failure to Disconnect 34 34
Improper or Incorrect Procedure or Method 34 34
Physical Resistance/Sticking 33 33
Peeled/Delaminated 33 33
Optical Problem 31 31
Complete Blockage 29 29
Suction Problem 28 28
Device Damaged by Another Device 27 27
Device Handling Problem 25 25
Corroded 24 24
Deformation Due to Compressive Stress 23 23
Insufficient Information 22 22
Material Deformation 22 22
Loss of or Failure to Bond 22 22
Crack 21 21
Use of Device Problem 19 19
Scratched Material 17 17
Moisture Damage 16 16
Mechanical Jam 15 15
Residue After Decontamination 15 15
Electrical /Electronic Property Problem 14 14

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 23681 23681
No Known Impact Or Consequence To Patient 1397 1397
No Consequences Or Impact To Patient 445 445
Hemorrhage/Bleeding 193 193
Perforation 167 167
Insufficient Information 157 157
Foreign Body In Patient 91 91
No Patient Involvement 85 85
Bacterial Infection 56 56
Unspecified Infection 42 42
Injury 37 37
Fever 35 35
Drug Resistant Bacterial Infection 27 27
Unspecified Tissue Injury 19 19
Pain 18 18
Pancreatitis 17 17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 17 17
Unspecified Hepatic or Biliary Problem 17 17
Abdominal Pain 16 16
Chest Pain 15 15
Laceration(s) 15 15
Stenosis 14 14
Peritonitis 14 14
Sepsis 12 12
Bowel Perforation 11 11
Pneumothorax 10 10
Gastrointestinal Hemorrhage 10 10
Unspecified Gastrointestinal Problem 10 10
Abrasion 10 10
Abscess 10 10
Chemical Exposure 8 8
Chills 7 7
Malaise 7 7
Pneumonia 7 7
Laceration(s) of Esophagus 7 7
Stenosis of the esophagus 6 6
Nausea 6 6
Fistula 6 6
Pleural Effusion 6 6
Muscle/Tendon Damage 6 6
No Code Available 5 5
Death 5 5
Internal Organ Perforation 5 5
Unspecified Respiratory Problem 5 5
Perforation of Esophagus 5 5
Swelling/ Edema 5 5
Thrombosis/Thrombus 4 4
Respiratory Tract Infection 4 4
Burn(s) 4 4
Vomiting 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Aomori Olympus Co., Ltd. II Sep-07-2023
2 Olympus Corporation of the Americas II Jun-21-2022
3 Olympus Corporation of the Americas II Nov-27-2020
-
-