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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device unit, cryosurgical, accessories
Product CodeGEH
Regulation Number 878.4350
Device Class 2


Premarket Reviews
ManufacturerDecision
ARRINEX, INC
  SUBSTANTIALLY EQUIVALENT 1
ARRINEX, INC.
  SUBSTANTIALLY EQUIVALENT 2
ATRICURE, INC
  SUBSTANTIALLY EQUIVALENT 1
ATRICURE, INC.
  SUBSTANTIALLY EQUIVALENT 1
B.M. TECH. WORLDWIDE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIBAWO MEDICAL A/S
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BOVIE MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
BRYMILL CRYOGENIC SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
C2 THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 5
COOL RENEWAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
CRY IQ AB
  SUBSTANTIALLY EQUIVALENT 1
CRYOCONCEPTS LP
  SUBSTANTIALLY EQUIVALENT 4
CRYOFOS MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
CRYOSURGERY, INC.
  SUBSTANTIALLY EQUIVALENT 1
CSA MEDIAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
CSA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 7
DGI TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
ERBE ELEKTROMEDIZIN GMBH
  SUBSTANTIALLY EQUIVALENT 1
GALIL MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 3
GALIL MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 2
H&O EQUIPMENTS, NV/SA
  SUBSTANTIALLY EQUIVALENT 1
HEALTH TRONICS
  SUBSTANTIALLY EQUIVALENT 1
ICECURE MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDILINK A/S
  SUBSTANTIALLY EQUIVALENT 1
MEDINUX (TIANJIN) TECHNOLOGIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDTECH PRODUCTS INC.
  SUBSTANTIALLY EQUIVALENT 2
NUANCE MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
PENTAX MEDICAL, A DIVISION OF PENTAX OF AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
PENTAX OF AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 2
PRONOVA LABORATORIES BV
  SUBSTANTIALLY EQUIVALENT 1
R2 DERMATOLOGY
  SUBSTANTIALLY EQUIVALENT 1
R2 DERMATOLOGY ,INC
  SUBSTANTIALLY EQUIVALENT 1
R2 TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
RECENS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
RECENSMEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
RECENSMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
THE OTC LAB HEALTHCARE B.V.
  SUBSTANTIALLY EQUIVALENT 1
VARIAN MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
YOZMA BMTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 143 143
2017 216 216
2018 208 208
2019 455 455
2020 277 278
2021 213 214
2022 230 230
2023 164 164
2024 34 34

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 320 320
Device Operates Differently Than Expected 239 239
Appropriate Term/Code Not Available 213 213
Temperature Problem 142 142
Excessive Cooling 110 110
Thermal Decomposition of Device 90 90
Gas/Air Leak 83 83
Defective Device 82 82
Insufficient Cooling 69 69
Break 65 65
Therapeutic or Diagnostic Output Failure 53 53
Leak/Splash 52 52
Mechanical Problem 51 51
Defective Component 51 51
Insufficient Heating 43 43
Insufficient Information 39 39
Physical Resistance/Sticking 27 27
Output Problem 27 27
Material Twisted/Bent 22 22
Use of Device Problem 20 20
Failure to Fire 18 18
Device Displays Incorrect Message 17 17
Noise, Audible 17 17
Incorrect, Inadequate or Imprecise Result or Readings 13 13
Fluid/Blood Leak 12 12
Crack 11 11
Burst Container or Vessel 11 11
Material Separation 11 11
No Apparent Adverse Event 11 11
Material Deformation 10 10
Loose or Intermittent Connection 10 10
Fire 9 9
Improper or Incorrect Procedure or Method 9 9
Device Inoperable 8 8
No Display/Image 8 8
Detachment of Device or Device Component 8 8
Device Operational Issue 7 7
Failure to Shut Off 7 7
Protective Measures Problem 7 7
Moisture or Humidity Problem 7 7
Electrical /Electronic Property Problem 7 7
Gas Output Problem 7 7
Material Rupture 7 7
Difficult to Remove 6 6
Misconnection 6 6
Loss of Power 6 6
Unintended Ejection 6 6
Device Alarm System 6 6
Contamination 6 6
Difficult to Open or Close 6 6
Failure of Device to Self-Test 6 6
Mechanics Altered 6 6
Connection Problem 6 6
Mechanical Jam 5 5
Pressure Problem 5 5
Explosion 5 5
Device Handling Problem 5 5
Activation Problem 5 5
Application Interface Becomes Non-Functional Or Program Exits Abnormally 5 5
Component Missing 5 5
Disconnection 4 4
Naturally Worn 4 4
Free or Unrestricted Flow 4 6
Operating System Becomes Nonfunctional 4 4
Difficult or Delayed Activation 4 4
Computer Operating System Problem 4 4
Patient-Device Incompatibility 3 3
Improper Flow or Infusion 3 3
No Pressure 3 3
Unintended Movement 3 3
Application Program Freezes, Becomes Nonfunctional 3 3
Firing Problem 3 3
Display or Visual Feedback Problem 3 3
Use of Incorrect Control/Treatment Settings 3 3
Fracture 3 3
Inflation Problem 3 3
Excess Flow or Over-Infusion 3 3
Computer Software Problem 3 3
Partial Blockage 3 3
Complete Blockage 3 3
Failure to Read Input Signal 3 3
Premature Activation 3 3
Unsealed Device Packaging 2 2
Failure to Power Up 2 2
Energy Output Problem 2 2
Moisture Damage 2 2
Self-Activation or Keying 2 2
Misfire 2 2
Detachment Of Device Component 2 2
Corroded 2 2
Material Fragmentation 2 2
Material Split, Cut or Torn 2 2
Failure to Deflate 2 2
Wrong Label 2 2
Misassembly by Users 2 4
Material Integrity Problem 2 2
Expulsion 2 2
Blocked Connection 2 2
Device Sensing Problem 2 2
Contamination /Decontamination Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 433 433
No Consequences Or Impact To Patient 321 321
No Clinical Signs, Symptoms or Conditions 319 319
Insufficient Information 121 121
Muscle Spasm(s) 117 117
Hemorrhage/Bleeding 48 48
No Code Available 44 44
No Information 42 42
Burn(s) 35 35
Fistula 35 35
Pneumothorax 34 34
Stenosis 34 34
No Patient Involvement 33 33
Burn, Thermal 32 32
Pain 31 31
Pleural Effusion 20 20
Necrosis 20 20
Hematoma 19 19
Injury 19 19
Partial thickness (Second Degree) Burn 18 18
Perforation 18 18
Cramp(s) /Muscle Spasm(s) 18 18
Epistaxis 17 17
Laceration(s) 15 15
Renal Failure 15 15
Superficial (First Degree) Burn 15 15
Caustic/Chemical Burns 15 15
Unspecified Infection 14 14
Patient Problem/Medical Problem 14 14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 14 14
Blood Loss 13 13
Dyspnea 11 11
Incontinence 10 10
Full thickness (Third Degree) Burn 10 10
Obstruction/Occlusion 10 10
Cryogenic Burn 10 12
Perforation of Esophagus 9 9
Respiratory Failure 9 9
Nerve Damage 9 9
Death 9 9
Cardiac Arrest 9 9
Arrhythmia 9 9
Dysphagia/ Odynophagia 8 8
Discomfort 8 8
Urinary Retention 8 8
Swelling/ Edema 8 8
Swelling 7 7
Tissue Damage 7 7
Numbness 7 7
Fatigue 7 7
Hemoptysis 6 6
Bradycardia 6 6
Scar Tissue 6 6
Urinary Tract Infection 6 6
Hematuria 6 6
Cancer 6 6
Loss of consciousness 5 5
Pseudoaneurysm 5 5
Vomiting 5 5
Laceration(s) of Esophagus 5 5
Muscle Weakness 5 5
Air Embolism 5 5
Muscle Stimulation 5 5
Abdominal Pain 4 4
Stroke/CVA 4 4
Erythema 4 4
Impotence 4 4
Inflammation 4 4
Internal Organ Perforation 4 4
Complaint, Ill-Defined 4 4
Abdominal Distention 4 4
Electric Shock 4 4
Foreign Body In Patient 4 4
Alteration In Body Temperature 4 4
Unspecified Tissue Injury 4 4
Erectile Dysfunction 4 4
Blister 3 5
Urethral Stenosis/Stricture 3 3
Bowel Perforation 3 3
Tissue Breakdown 3 3
Fluid Discharge 3 3
Tachycardia 3 3
Skin Irritation 3 3
Paralysis 3 3
Skin Discoloration 3 3
Myocardial Infarction 3 3
Undesired Nerve Stimulation 3 3
Hearing Impairment 3 3
Headache 2 2
Diarrhea 2 2
Edema 2 2
Chest Pain 2 2
Bacterial Infection 2 2
Cardiomyopathy 2 2
Cardiopulmonary Arrest 2 2
Cellulitis 2 2
Neuropathy 2 2
Nausea 2 2
Low Blood Pressure/ Hypotension 2 2
Seizures 2 2

Recalls
Manufacturer Recall Class Date Posted
1 AtriCure, Inc. II Jan-31-2024
2 Boston Scientific Corporation II Dec-22-2020
3 Boston Scientific Corporation II Oct-23-2020
4 Boston Scientific Corporation II Jul-21-2020
5 C2 Therapeutics, Inc. II Mar-15-2017
6 Galil Medical, Inc. II Nov-14-2019
7 Icecure Medical Ltd II Sep-29-2023
8 OraSure Technologies, Inc. III Sep-23-2020
9 PENTAX of America Inc II May-14-2019
10 PENTAX of America Inc II Mar-01-2019
11 PENTAX of America Inc II Jun-05-2018
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