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
Regulation Description Endoscope and accessories.
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
ACTUATED MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ALTON (SHANGHAI) MEDICAL INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
AMBU A/S
  SUBSTANTIALLY EQUIVALENT 2
EVOENDO, INC.
  SUBSTANTIALLY EQUIVALENT 4
FUJIFILM CORPORATION
  SUBSTANTIALLY EQUIVALENT 7
FUJIFILM CORPORATON
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM HEALTHCARE AMERICAS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
INTUITIVE SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
IQ ENDOSCOPES LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MICRO-TECH (NANJING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NEPTUNE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PENTAX OF AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2021 1755 1756
2022 6216 6240
2023 9874 9883
2024 9258 9258
2025 19075 19078
2026 24199 24200

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Clean Adequately 20821 20832
Poor Quality Image 8196 8206
Communication or Transmission Problem 5666 5666
No Display/Image 5529 5530
Device Reprocessing Problem 5284 5290
Erratic or Intermittent Display 4003 4003
Residue After Decontamination 3866 3866
Break 2580 2580
Microbial Contamination of Device 2159 2160
Fluid/Blood Leak 2063 2063
Obstruction of Flow 2013 2014
Corroded 1530 1530
Contamination 1115 1122
Detachment of Device or Device Component 1095 1095
Optical Obstruction 1069 1069
Thermal Decomposition of Device 1034 1034
Melted 875 875
Image Display Error/Artifact 727 728
Overheating of Device 629 629
Contamination /Decontamination Problem 618 618
Flare or Flash 570 570
Misfocusing 510 510
Device Contamination with Chemical or Other Material 470 470
Adverse Event Without Identified Device or Use Problem 449 451
Crack 419 419
Optical Distortion 364 364
Gas/Air Leak 342 342
Degraded 325 325
Material Deformation 306 306
Display or Visual Feedback Problem 292 294
Material Split, Cut or Torn 278 278
Connection Problem 206 206
Unintended Movement 206 206
Scratched Material 200 200
Material Discolored 180 180
Dent in Material 178 178
Peeled/Delaminated 175 176
Electrical /Electronic Property Problem 157 157
Loose or Intermittent Connection 150 150
Optical Problem 142 142
Physical Resistance/Sticking 136 136
Collapse 132 132
Component Missing 131 131
Positioning Failure 113 113
Mechanical Jam 111 111
Improper Flow or Infusion 110 110
Moisture Damage 97 97
Complete Blockage 96 96
No Flow 90 90
Mechanical Problem 88 88

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 69233 69268
Insufficient Information 395 395
Hemorrhage/Blood Loss/Bleeding 222 224
Perforation 163 163
Foreign Body In Patient 106 107
No Consequences Or Impact To Patient 71 71
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 70 70
Bacterial Infection 59 59
Unspecified Infection 53 53
Fever 44 44
Gastrointestinal Hemorrhage 37 37
Drug Resistant Bacterial Infection 30 30
Bowel Perforation 28 28
Abdominal Pain 25 25
Unspecified Tissue Injury 24 24
Pancreatitis 22 22
Pain 18 18
No Patient Involvement 18 18
Peritonitis 18 18
Unspecified Hepatic or Biliary Problem 17 17
Chest Pain 16 16
Stenosis 14 14
Pneumothorax 13 13
Sepsis 12 12
Pneumoperitoneum 11 11
Laceration(s) 11 11
Unspecified Gastrointestinal Problem 11 11
Perforation of Esophagus 10 10
Abscess 9 9
Fistula 8 8
Pleural Effusion 8 8
Pneumonia 7 7
Stenosis of the esophagus 7 7
Chills 7 7
High White Blood Cell Count 7 7
Muscle/Tendon Damage 7 7
Laceration(s) of Esophagus 7 7
Malaise 7 7
Pulmonary Emphysema 7 7
Nausea 7 7
Internal Organ Perforation 7 7
Abrasion 6 6
Bacteremia 6 6
Bronchospasm 6 6
Swelling/ Edema 6 6
Cardiac Arrest 5 5
Unspecified Respiratory Problem 5 5
Hematemesis 5 5
Aspiration Pneumonitis 5 5
Hematoma 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Aomori Olympus Co., Ltd. II Sep-07-2023
2 Olympus Corporation of the Americas II Dec-05-2024
3 Olympus Corporation of the Americas II Nov-20-2024
4 Olympus Corporation of the Americas II Jun-21-2022
-
-