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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device unit, electrosurgical, endoscopic (with or without accessories)
Regulation Description Endoscopic electrosurgical unit and 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
BEIJING ZKSK TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
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
SB-KAWASUMI LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
STARMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TAEWOONG MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WILSON-COOK MEDICAL INC.
  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
2020 906 906
2021 814 814
2022 913 913
2023 979 979
2024 1531 1531
2025 363 363

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2621 2621
Adverse Event Without Identified Device or Use Problem 1462 1462
Detachment of Device or Device Component 355 355
Material Deformation 209 209
Material Separation 186 186
Material Split, Cut or Torn 172 172
Device Dislodged or Dislocated 101 101
Off-Label Use 99 99
Peeled/Delaminated 82 82
Melted 72 72
Use of Device Problem 69 69
Device Contaminated During Manufacture or Shipping 68 68
Positioning Problem 62 62
Mechanical Problem 61 61
Material Integrity Problem 59 59
Material Twisted/Bent 56 56
Defective Device 52 52
Failure to Fold 52 52
Malposition of Device 46 46
Failure to Conduct 46 46
Device Contamination with Chemical or Other Material 42 42
Insufficient Information 41 41
Material Fragmentation 36 36
Retraction Problem 33 33
Failure to Deliver Energy 31 31
Failure to Align 30 30
Sparking 29 29
Difficult to Advance 29 29
Fracture 29 29
Failure to Cut 25 25
Thermal Decomposition of Device 22 22
Sharp Edges 19 19
Device Displays Incorrect Message 17 17
Appropriate Term/Code Not Available 17 17
Crack 13 13
Temperature Problem 13 13
Activation, Positioning or Separation Problem 13 13
Output Problem 11 11
Tear, Rip or Hole in Device Packaging 11 11
Pressure Problem 11 11
Activation Failure 11 11
Unsealed Device Packaging 10 10
Improper or Incorrect Procedure or Method 9 9
Positioning Failure 9 9
Therapeutic or Diagnostic Output Failure 9 9
Material Protrusion/Extrusion 8 8
Physical Resistance/Sticking 7 7
Energy Output Problem 7 7
Difficult to Remove 7 7
Packaging Problem 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3322 3322
No Consequences Or Impact To Patient 603 603
Hemorrhage/Bleeding 445 445
Perforation 441 441
Urinary Retention 145 145
Pain 125 125
Foreign Body In Patient 121 121
Insufficient Information 101 101
Hematuria 89 89
Urinary Tract Infection 83 83
Micturition Urgency 76 76
Fever 69 69
Dysuria 65 65
Pancreatitis 61 61
Urinary Frequency 58 58
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 57 57
Gastrointestinal Hemorrhage 51 51
Inflammation 50 50
Unspecified Infection 45 45
Stenosis 40 40
Unspecified Tissue Injury 39 39
Abdominal Pain 37 37
No Known Impact Or Consequence To Patient 34 34
Bowel Perforation 34 34
Urinary Incontinence 32 32
No Code Available 31 31
Sepsis 30 30
Peritonitis 30 30
Internal Organ Perforation 29 29
Bacterial Infection 29 29
Necrosis 25 25
Swelling/ Edema 23 23
Discomfort 21 21
Patient Problem/Medical Problem 20 20
Obstruction/Occlusion 20 20
Stenosis of the esophagus 16 16
Scar Tissue 16 16
Unspecified Hepatic or Biliary Problem 15 15
Urethral Stenosis/Stricture 15 15
Burn(s) 14 14
Sexual Dysfunction 14 14
Hematoma 14 14
Blood Loss 14 14
Abscess 14 14
No Patient Involvement 12 12
Unspecified Kidney or Urinary Problem 12 12
Erectile Dysfunction 12 12
Cramp(s) /Muscle Spasm(s) 11 11
Pleural Effusion 11 11
Fistula 11 11

Recalls
Manufacturer Recall Class Date Posted
1 Aomori Olympus Co., Ltd. II Feb-05-2021
2 Boston Scientific Corporation II Jan-29-2025
3 Boston Scientific Corporation II Jul-12-2024
4 Boston Scientific Corporation II Apr-18-2023
5 Boston Scientific Corporation II Mar-11-2022
6 Olympus Corporation of the Americas II Sep-12-2024
7 Olympus Corporation of the Americas II Apr-05-2024
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