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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 4
BEIJING ZKSK TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
CREO MEDICAL, LTD.
  SUBSTANTIALLY EQUIVALENT 3
FRANCIS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
G-FLEX EUROPE SPRL
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU AGS MEDTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
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
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
SB-KAWASUMI LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
STARMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TAEWOONG MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
WILSON-COOK MEDICAL
  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
2021 814 815
2022 913 914
2023 976 976
2024 1534 1534
2025 1527 1527
2026 822 847

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2883 2883
Adverse Event Without Identified Device or Use Problem 1989 2016
Detachment of Device or Device Component 442 442
Material Deformation 269 269
Use of Device Problem 215 215
Material Separation 176 176
Material Split, Cut or Torn 169 169
Positioning Problem 113 113
Positioning Failure 104 104
Device Dislodged or Dislocated 101 101
Peeled/Delaminated 98 98
Mechanical Problem 89 89
Off-Label Use 89 89
Activation Failure 86 86
Activation, Positioning or Separation Problem 79 79
Material Integrity Problem 77 77
Deformation Due to Compressive Stress 77 77
Device Contamination with Chemical or Other Material 76 76
Device Contaminated During Manufacture or Shipping 76 76
Melted 75 75
Material Twisted/Bent 69 69
Fracture 66 66
Difficult to Advance 66 66
Retraction Problem 62 62
Failure to Fold 61 61
Defective Device 59 59
Material Fragmentation 57 57
Failure to Conduct 52 52
Failure to Align 50 50
Insufficient Information 33 33
Sparking 28 28
Thermal Decomposition of Device 26 26
Failure to Deliver Energy 26 26
Sharp Edges 24 24
Migration 22 22
Entrapment of Device 18 18
Device Displays Incorrect Message 18 18
Pressure Problem 18 18
Failure to Cut 18 18
Temperature Problem 18 18
Difficult to Remove 17 17
Nonstandard Device 14 14
Device Stenosis 14 14
Difficult or Delayed Positioning 14 14
Difficult or Delayed Activation 14 14
Electrical /Electronic Property Problem 13 13
Crack 13 13
Tear, Rip or Hole in Device Packaging 13 13
Physical Resistance/Sticking 11 11
Improper or Incorrect Procedure or Method 11 11

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4697 4697
Hemorrhage/Bleeding 521 522
Perforation 348 348
Urinary Retention 276 277
Urinary Tract Infection 223 223
Hematuria 212 213
Foreign Body In Patient 140 140
Pain 135 136
Micturition Urgency 133 133
Insufficient Information 126 127
Dysuria 112 113
Inflammation 97 97
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 92 93
Fever 90 90
Unspecified Infection 86 86
Pancreatitis 86 86
Urinary Frequency 79 79
Gastrointestinal Hemorrhage 73 73
Unspecified Tissue Injury 69 69
Urinary Incontinence 57 58
Bowel Perforation 57 57
Abdominal Pain 53 53
No Consequences Or Impact To Patient 45 45
Peritonitis 40 40
Sexual Dysfunction 38 38
Sepsis 36 36
Stenosis 33 34
Swelling/ Edema 32 32
Necrosis 32 32
Discomfort 31 31
Internal Organ Perforation 30 30
Bacterial Infection 27 27
Obstruction/Occlusion 25 25
Urethral Stenosis/Stricture 24 24
Erectile Dysfunction 22 22
Pleural Effusion 22 22
Hematoma 22 22
Fistula 19 19
Abscess 19 19
Stenosis of the esophagus 18 18
Unspecified Hepatic or Biliary Problem 18 18
Scar Tissue 17 17
Perforation of Esophagus 16 16
Cramp(s) /Muscle Spasm(s) 15 15
Pneumonia 14 14
Unspecified Kidney or Urinary Problem 14 14
Burn(s) 13 13
Vomiting 11 11
Aspiration Pneumonitis 10 10
Syncope/Fainting 10 10

Recalls
Manufacturer Recall Class Date Posted
1 Aomori Olympus Co., Ltd. II Feb-05-2021
2 Boston Scientific Corporation I Feb-05-2026
3 Boston Scientific Corporation II Jan-29-2025
4 Boston Scientific Corporation II Jul-12-2024
5 Boston Scientific Corporation II Apr-18-2023
6 Boston Scientific Corporation II Mar-11-2022
7 Olympus Corporation of the Americas II Feb-05-2026
8 Olympus Corporation of the Americas II Jan-30-2026
9 Olympus Corporation of the Americas II Sep-12-2024
10 Olympus Corporation of the Americas II Apr-05-2024
11 Wilson-Cook Medical Inc. II Feb-13-2026
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