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TPLC
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Device
unit, electrosurgical, endoscopic (with or without accessories)
Product Code
KNS
Regulation Number
876.4300
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
1
CREO MEDICAL LTD.
SUBSTANTIALLY EQUIVALENT - KIT
1
G-FLEX EUROPE SPRL
SUBSTANTIALLY EQUIVALENT
1
HANGZHOU AGS MEDTECH CO., LTD.
SUBSTANTIALLY EQUIVALENT
3
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
320
320
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
2181
2181
Adverse Event Without Identified Device or Use Problem
1159
1159
Detachment of Device or Device Component
198
198
Material Deformation
167
167
Material Separation
167
167
Material Split, Cut or Torn
144
144
Device Dislodged or Dislocated
89
89
Failure to Align
89
89
Positioning Problem
80
80
Off-Label Use
71
71
Peeled/Delaminated
68
68
Melted
67
67
Material Twisted/Bent
59
59
Mechanical Problem
54
54
Failure to Conduct
49
49
Failure to Fold
48
48
Use of Device Problem
48
48
Material Integrity Problem
48
48
Malposition of Device
47
47
Failure to Deliver Energy
47
47
Defective Device
41
41
Insufficient Information
39
39
Material Fragmentation
29
29
Failure to Cut
27
27
Retraction Problem
23
23
Fracture
22
22
Appropriate Term/Code Not Available
22
22
Difficult to Advance
22
22
Sharp Edges
18
18
Sparking
18
18
Device Displays Incorrect Message
12
12
Device Contamination with Chemical or Other Material
12
12
Output Problem
11
11
Pressure Problem
11
11
Improper or Incorrect Procedure or Method
11
11
Tear, Rip or Hole in Device Packaging
9
9
Crack
9
9
Physical Resistance/Sticking
9
9
Therapeutic or Diagnostic Output Failure
8
8
Difficult to Remove
8
8
Unsealed Device Packaging
7
7
Temperature Problem
7
7
Material Protrusion/Extrusion
7
7
Material Frayed
6
6
No Device Output
6
6
Leak/Splash
5
5
Contamination
5
5
Component Missing
5
5
Problem with Sterilization
5
5
Device Contaminated During Manufacture or Shipping
5
5
Packaging Problem
5
5
Device Fell
5
5
Infusion or Flow Problem
4
4
Obstruction of Flow
4
4
Activation, Positioning or Separation Problem
4
4
Deformation Due to Compressive Stress
4
4
Failure to Prime
4
4
Thermal Decomposition of Device
4
4
Energy Output Problem
4
4
Nonstandard Device
3
3
Electrical /Electronic Property Problem
3
3
Failure to Power Up
3
3
Structural Problem
3
3
Device-Device Incompatibility
3
3
Activation Failure
3
3
Activation Problem
3
3
Output below Specifications
2
2
Impedance Problem
2
2
Flare or Flash
2
2
Difficult to Open or Close
2
2
Dull, Blunt
2
2
Failure to Advance
2
2
Material Puncture/Hole
2
2
Device Slipped
2
2
Electro-Static Discharge
2
2
Device Damaged Prior to Use
2
2
Defective Component
2
2
Entrapment of Device
2
2
Unintended System Motion
2
2
Overheating of Device
2
2
Fluid/Blood Leak
2
2
Loose or Intermittent Connection
1
1
Insufficient Heating
1
1
Inflation Problem
1
1
Labelling, Instructions for Use or Training Problem
1
1
Inadequate Instructions for Healthcare Professional
1
1
Delivered as Unsterile Product
1
1
Migration or Expulsion of Device
1
1
Fire
1
1
Loss of or Failure to Bond
1
1
Failure to Capture
1
1
Device Reprocessing Problem
1
1
Complete Blockage
1
1
Positioning Failure
1
1
Disconnection
1
1
Material Disintegration
1
1
Smoking
1
1
Failure to Deliver
1
1
Product Quality Problem
1
1
Premature Activation
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
2137
2137
No Consequences Or Impact To Patient
1060
1060
Perforation
400
400
Hemorrhage/Bleeding
338
338
Pain
107
107
No Known Impact Or Consequence To Patient
102
102
Urinary Retention
100
100
Foreign Body In Patient
92
92
Insufficient Information
81
81
Hematuria
59
59
Urinary Tract Infection
57
57
Micturition Urgency
51
51
Patient Problem/Medical Problem
45
45
Dysuria
44
44
Urinary Frequency
42
42
Pancreatitis
40
40
Fever
39
39
Stenosis
37
37
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
36
36
Unspecified Infection
34
34
No Code Available
34
34
Inflammation
34
34
Gastrointestinal Hemorrhage
32
32
Bowel Perforation
27
27
No Patient Involvement
27
27
Blood Loss
24
24
Sepsis
23
23
Abdominal Pain
23
23
Unspecified Tissue Injury
21
21
Discomfort
21
21
Bacterial Infection
21
21
Urinary Incontinence
20
20
Incontinence
18
18
Injury
17
17
Necrosis
15
15
Peritonitis
15
15
Unspecified Hepatic or Biliary Problem
15
15
Obstruction/Occlusion
13
13
Swelling/ Edema
13
13
Abscess
12
12
Perforation of Esophagus
12
12
Scar Tissue
11
11
Internal Organ Perforation
11
11
Burn(s)
11
11
Stenosis of the esophagus
10
10
Device Embedded In Tissue or Plaque
9
9
Erectile Dysfunction
9
9
Muscle Spasm(s)
9
9
Hemostasis
8
8
Hematoma
7
7
Urethral Stenosis/Stricture
7
7
Muscle/Tendon Damage
6
6
Impotence
6
6
Death
6
6
Cramp(s) /Muscle Spasm(s)
5
5
Pleural Effusion
5
5
Burning Sensation
5
5
Complaint, Ill-Defined
5
5
Pneumonia
5
5
Unspecified Gastrointestinal Problem
5
5
Aspiration Pneumonitis
4
4
Fistula
4
4
Needle Stick/Puncture
4
4
Electric Shock
4
4
Thromboembolism
4
4
No Information
4
4
Unspecified Kidney or Urinary Problem
4
4
Nausea
4
4
Chills
4
4
Pulmonary Embolism
3
3
Hematemesis
3
3
Sexual Dysfunction
3
3
Bradycardia
3
3
Anxiety
3
3
Laceration(s)
3
3
Unspecified Respiratory Problem
3
3
Edema
3
3
Syncope/Fainting
3
3
Renal Failure
3
3
Occlusion
3
3
Fluid Discharge
3
3
Dizziness
3
3
Vomiting
3
3
Chest Pain
3
3
Laceration(s) of Esophagus
3
3
Pneumothorax
3
3
Numbness
3
3
Cognitive Changes
2
2
Unspecified Mental, Emotional or Behavioural Problem
2
2
Melena
2
2
Depression
2
2
Undesired Nerve Stimulation
2
2
Loss of consciousness
2
2
Unspecified Reproductive System or Breast Problem
2
2
Diaphoresis
2
2
Dyspnea
2
2
Skin Inflammation/ Irritation
2
2
Myocardial Infarction
2
2
Hypoxia
2
2
Ulcer
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
Aomori Olympus Co., Ltd.
II
Feb-05-2021
2
Boston Scientific Corporation
II
Apr-18-2023
3
Boston Scientific Corporation
II
Mar-11-2022
4
Wilson-Cook Medical Inc.
II
Apr-12-2019
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