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TPLC
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Device
sterilizer, chemical
Regulation Description
Ethylene oxide gas sterilizer.
Product Code
MLR
Regulation Number
880.6860
Device Class
2
Premarket Reviews
Manufacturer
Decision
ADVANCED STERILIZATION PRODUCTS
SUBSTANTIALLY EQUIVALENT
1
ADVANCED STERILIZATION PRODUCTS, INC.
SUBSTANTIALLY EQUIVALENT
2
IDEATE MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
LOWTEM CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
PLASMAPP CO,.LTD
SUBSTANTIALLY EQUIVALENT
1
PLASMAPP CO., LTD.
SUBSTANTIALLY EQUIVALENT
3
1. K220345
STERLINK mini Sterilizer with STERLOAD mini Casset
...
2. K223015
STERLINK™ FPS-15s Plus sterilizer with STERPACK™ p
...
3. K231169
STERLINK plus Sterilizer with STERLOAD Cassette, T
...
STERIS
SUBSTANTIALLY EQUIVALENT
2
STERIS CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
174
174
2021
202
202
2022
188
188
2023
140
140
2024
44
44
2025
5
5
Device Problems
MDRs with this Device Problem
Events in those MDRs
Environmental Particulates
305
305
Device Emits Odor
255
255
Smoking
69
69
Use of Device Problem
53
53
Device Handling Problem
21
21
Fluid/Blood Leak
18
18
Leak/Splash
15
15
Adverse Event Without Identified Device or Use Problem
14
14
Insufficient Information
14
14
Fire
8
8
Improper or Incorrect Procedure or Method
8
8
Gas/Air Leak
7
7
Appropriate Term/Code Not Available
6
6
Pressure Problem
4
4
Chemical Problem
3
3
Patient-Device Incompatibility
3
3
Therapeutic or Diagnostic Output Failure
3
3
Fumes or Vapors
2
2
Device Damaged Prior to Use
2
2
Fogging
2
2
Thermal Decomposition of Device
2
2
Excessive Heating
1
1
Ejection Problem
1
1
Expiration Date Error
1
1
Moisture or Humidity Problem
1
1
Material Integrity Problem
1
1
Failure to Align
1
1
Device Reprocessing Problem
1
1
No Apparent Adverse Event
1
1
Defective Component
1
1
Failure to Calibrate
1
1
Sparking
1
1
Shipping Damage or Problem
1
1
Failure to Cycle
1
1
Output Problem
1
1
Inadequate or Insufficient Training
1
1
Temperature Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
407
407
No Consequences Or Impact To Patient
169
169
Burn(s)
58
58
Insufficient Information
27
27
Skin Discoloration
19
19
Skin Irritation
14
14
Headache
13
13
Skin Burning Sensation
12
12
Burning Sensation
9
9
Superficial (First Degree) Burn
5
5
Itching Sensation
5
5
Eye Burn
4
4
Unspecified Respiratory Problem
4
4
Dyspnea
4
4
Burn, Thermal
4
4
Dizziness
4
4
Red Eye(s)
3
3
Caustic/Chemical Burns
3
3
Irritation
3
3
Eye Pain
3
3
Nausea
3
3
Pain
3
3
No Code Available
3
3
No Known Impact Or Consequence To Patient
2
2
Swelling/ Edema
2
2
Injury
2
2
Cough
2
2
Swelling
1
1
Sore Throat
1
1
Damage to Ligament(s)
1
1
Rash
1
1
Reaction to Medicinal Component of Device
1
1
Reaction
1
1
Bone Fracture(s)
1
1
Fever
1
1
Hematoma
1
1
Pneumonia
1
1
Blurred Vision
1
1
High Blood Pressure/ Hypertension
1
1
Skin Inflammation/ Irritation
1
1
Discomfort
1
1
Erythema
1
1
Tachycardia
1
1
Unspecified Eye / Vision Problem
1
1
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