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 unit, electrosurgical, endoscopic (with or without accessories)
Product CodeKNS
Regulation Number 876.4300
Device Class 2


Premarket Reviews
ManufacturerDecision
ANREI MEDICAL (HANGZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
AQUA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
CREO MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 2
CREO MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT - KIT 1
G-FLEX EUROPE SPRL
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU AGS MEDTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
JIANGSU VEDKANG MEDICAL SCIENCE AND TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
LAMIDEY NOURY MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MICRO-TECH (NANJING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NXTHERA (A BOSTON SCIENTIFIC COMPANY)
  SUBSTANTIALLY EQUIVALENT 2
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 2
STARMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SUMITOMO BAKELITE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
TAEWOONG MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WILSON-COOK MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG SOUDON MEDICAL TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 668 668
2020 906 906
2021 814 814
2022 914 914
2023 979 979
2024 1053 1053

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2530 2530
Adverse Event Without Identified Device or Use Problem 1349 1349
Detachment of Device or Device Component 297 297
Material Deformation 194 194
Material Separation 183 183
Material Split, Cut or Torn 168 168
Off-Label Use 102 102
Device Dislodged or Dislocated 95 95
Failure to Align 92 92
Peeled/Delaminated 80 80
Positioning Problem 80 80
Melted 70 70
Material Twisted/Bent 62 62
Mechanical Problem 58 58
Use of Device Problem 54 54
Failure to Deliver Energy 52 52
Failure to Conduct 52 52
Failure to Fold 51 51
Material Integrity Problem 51 51
Defective Device 49 49
Malposition of Device 47 47
Insufficient Information 41 41
Device Contamination with Chemical or Other Material 36 36
Material Fragmentation 31 31
Retraction Problem 29 29
Difficult to Advance 28 28
Failure to Cut 27 27
Sparking 23 23
Fracture 22 22
Appropriate Term/Code Not Available 22 22
Sharp Edges 21 21
Device Displays Incorrect Message 15 15
Crack 14 14
Output Problem 13 13
Pressure Problem 12 12
Improper or Incorrect Procedure or Method 11 11
Thermal Decomposition of Device 10 10
Tear, Rip or Hole in Device Packaging 10 10
Therapeutic or Diagnostic Output Failure 10 10
Physical Resistance/Sticking 9 9
Temperature Problem 9 9
Unsealed Device Packaging 8 8
Difficult to Remove 8 8
Material Protrusion/Extrusion 7 7
Device Contaminated During Manufacture or Shipping 7 7
Device Fell 6 6
Component Missing 6 6
No Device Output 6 6
Material Frayed 6 6
Packaging Problem 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2680 2680
No Consequences Or Impact To Patient 1060 1060
Perforation 422 422
Hemorrhage/Bleeding 383 383
Urinary Retention 133 133
Pain 125 125
Foreign Body In Patient 109 109
No Known Impact Or Consequence To Patient 102 102
Insufficient Information 87 87
Hematuria 81 81
Urinary Tract Infection 78 78
Micturition Urgency 74 74
Dysuria 66 66
Fever 55 55
Urinary Frequency 52 52
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 47 47
Inflammation 47 47
Gastrointestinal Hemorrhage 46 46
Patient Problem/Medical Problem 45 45
Pancreatitis 45 45
Unspecified Infection 43 43
Stenosis 37 37
No Code Available 34 34
Bacterial Infection 29 29
Unspecified Tissue Injury 28 28
Bowel Perforation 27 27
Sepsis 27 27
No Patient Involvement 27 27
Urinary Incontinence 26 26
Abdominal Pain 26 26
Blood Loss 24 24
Necrosis 23 23
Discomfort 23 23
Peritonitis 19 19
Incontinence 18 18
Swelling/ Edema 18 18
Injury 17 17
Internal Organ Perforation 16 16
Stenosis of the esophagus 15 15
Unspecified Hepatic or Biliary Problem 15 15
Obstruction/Occlusion 15 15
Abscess 14 14
Hematoma 14 14
Scar Tissue 14 14
Perforation of Esophagus 12 12
Erectile Dysfunction 11 11
Unspecified Kidney or Urinary Problem 11 11
Device Embedded In Tissue or Plaque 11 11
Burn(s) 11 11
Pleural Effusion 10 10

Recalls
Manufacturer Recall Class Date Posted
1 Aomori Olympus Co., Ltd. II Feb-05-2021
2 Boston Scientific Corporation II Jul-12-2024
3 Boston Scientific Corporation II Apr-18-2023
4 Boston Scientific Corporation II Mar-11-2022
5 Olympus Corporation of the Americas II Sep-12-2024
6 Olympus Corporation of the Americas II Apr-05-2024
7 Wilson-Cook Medical Inc. II Apr-12-2019
-
-