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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
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
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 60 60

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2449 2449
Adverse Event Without Identified Device or Use Problem 1388 1388
Detachment of Device or Device Component 333 333
Material Deformation 196 196
Material Separation 178 178
Material Split, Cut or Torn 172 172
Off-Label Use 99 99
Device Dislodged or Dislocated 98 98
Peeled/Delaminated 71 71
Melted 71 71
Device Contaminated During Manufacture or Shipping 67 67
Mechanical Problem 59 59
Use of Device Problem 59 59
Material Integrity Problem 55 55
Positioning Problem 54 54
Material Twisted/Bent 54 54
Defective Device 50 50
Failure to Fold 50 50
Malposition of Device 46 46
Failure to Conduct 44 44
Insufficient Information 41 41
Device Contamination with Chemical or Other Material 39 39
Retraction Problem 32 32
Material Fragmentation 30 30
Difficult to Advance 29 29
Failure to Deliver Energy 29 29
Failure to Align 27 27
Sparking 26 26
Failure to Cut 24 24
Fracture 24 24
Thermal Decomposition of Device 19 19
Sharp Edges 19 19
Appropriate Term/Code Not Available 17 17
Device Displays Incorrect Message 16 16
Crack 13 13
Pressure Problem 11 11
Temperature Problem 11 11
Tear, Rip or Hole in Device Packaging 11 11
Output Problem 11 11
Activation Failure 9 9
Activation, Positioning or Separation Problem 9 9
Therapeutic or Diagnostic Output Failure 9 9
Material Protrusion/Extrusion 8 8
Improper or Incorrect Procedure or Method 8 8
Positioning Failure 7 7
Physical Resistance/Sticking 7 7
Difficult to Remove 7 7
Energy Output Problem 7 7
Packaging Problem 6 6
Unsealed Device Packaging 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3085 3085
No Consequences Or Impact To Patient 603 603
Perforation 435 435
Hemorrhage/Bleeding 435 435
Urinary Retention 135 135
Pain 120 120
Foreign Body In Patient 110 110
Insufficient Information 97 97
Hematuria 78 78
Urinary Tract Infection 75 75
Micturition Urgency 72 72
Fever 65 65
Dysuria 64 64
Pancreatitis 59 59
Urinary Frequency 57 57
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 54 54
Gastrointestinal Hemorrhage 48 48
Inflammation 47 47
Unspecified Infection 44 44
Unspecified Tissue Injury 39 39
Stenosis 39 39
Abdominal Pain 35 35
No Known Impact Or Consequence To Patient 34 34
Urinary Incontinence 32 32
No Code Available 31 31
Bacterial Infection 29 29
Bowel Perforation 29 29
Sepsis 28 28
Necrosis 24 24
Swelling/ Edema 21 21
Patient Problem/Medical Problem 20 20
Discomfort 20 20
Peritonitis 19 19
Obstruction/Occlusion 18 18
Stenosis of the esophagus 16 16
Internal Organ Perforation 16 16
Unspecified Hepatic or Biliary Problem 15 15
Scar Tissue 15 15
Abscess 14 14
Blood Loss 14 14
Hematoma 13 13
Burn(s) 13 13
Sexual Dysfunction 12 12
Unspecified Kidney or Urinary Problem 12 12
Urethral Stenosis/Stricture 12 12
No Patient Involvement 12 12
Fistula 11 11
Pleural Effusion 11 11
Erectile Dysfunction 11 11
Cramp(s) /Muscle Spasm(s) 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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