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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
BIBAWO MEDICAL A/S
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BRYMILL CRYOGENIC SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
CRYOCONCEPTS LP
  SUBSTANTIALLY EQUIVALENT 3
CRYOSURGERY, INC.
  SUBSTANTIALLY EQUIVALENT 1
CSA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
DGI TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
ERBE ELEKTROMEDIZIN GMBH
  SUBSTANTIALLY EQUIVALENT 1
GALIL MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
ICECURE MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDILINK A/S
  SUBSTANTIALLY EQUIVALENT 1
MEDINUX (TIANJIN) TECHNOLOGIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NUANCE MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
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 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
2019 455 455
2020 277 278
2021 213 214
2022 230 230
2023 164 164
2024 30 30

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 219 219
Appropriate Term/Code Not Available 177 177
Temperature Problem 120 120
Thermal Decomposition of Device 89 89
Excessive Cooling 83 83
Defective Device 81 81
Gas/Air Leak 74 74
Insufficient Cooling 67 67
Break 61 61
Therapeutic or Diagnostic Output Failure 53 53
Leak/Splash 51 51
Mechanical Problem 49 49
Defective Component 48 48
Insufficient Heating 42 42
Output Problem 26 26
Physical Resistance/Sticking 26 26
Insufficient Information 23 23
Material Twisted/Bent 21 21
Use of Device Problem 20 20
Noise, Audible 14 14
Incorrect, Inadequate or Imprecise Result or Readings 13 13
Failure to Fire 13 13
Fluid/Blood Leak 11 11
Crack 10 10
Material Deformation 10 10
Loose or Intermittent Connection 9 9
Material Separation 9 9
Failure to Shut Off 7 7
Moisture or Humidity Problem 6 6
Material Rupture 6 6
Difficult to Remove 6 6
Improper or Incorrect Procedure or Method 6 6
Device Displays Incorrect Message 6 6
Gas Output Problem 6 6
Device Alarm System 6 6
Burst Container or Vessel 5 5
Contamination 5 5
Detachment of Device or Device Component 5 5
Difficult to Open or Close 5 5
Mechanical Jam 5 5
Explosion 5 5
Pressure Problem 5 5
Activation Problem 5 5
No Apparent Adverse Event 4 4
Device Handling Problem 4 4
Naturally Worn 4 4
Difficult or Delayed Activation 4 4
Free or Unrestricted Flow 3 5
No Pressure 3 3
Operating System Becomes Nonfunctional 3 3
Unintended Movement 3 3
Firing Problem 3 3
Component Missing 3 3
Excess Flow or Over-Infusion 3 3
Failure to Read Input Signal 3 3
Complete Blockage 3 3
Disconnection 3 3
No Display/Image 3 3
Use of Incorrect Control/Treatment Settings 3 3
Fracture 3 3
Unintended Ejection 3 3
Fire 3 3
Premature Activation 3 3
Energy Output Problem 2 2
Loss of Power 2 2
Failure to Power Up 2 2
Electrical /Electronic Property Problem 2 2
Corroded 2 2
Partial Blockage 2 2
Self-Activation or Keying 2 2
Connection Problem 2 2
Improper Flow or Infusion 2 2
Patient-Device Incompatibility 2 2
Blocked Connection 2 2
Contamination /Decontamination Problem 2 2
Wrong Label 2 2
Failure to Deflate 2 2
Material Split, Cut or Torn 2 2
Protective Measures Problem 2 2
Misassembly by Users 2 4
Mechanics Altered 2 2
Positioning Problem 1 1
Power Problem 1 1
Scratched Material 1 1
Activation Failure 1 1
Key or Button Unresponsive/not Working 1 1
Unexpected Shutdown 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Incomplete or Inadequate Connection 1 1
Computer Operating System Problem 1 1
Malposition of Device 1 1
Inappropriate or Unexpected Reset 1 1
Infusion or Flow Problem 1 1
Activation, Positioning or Separation Problem 1 1
Smoking 1 1
Incorrect Interpretation of Signal 1 1
Inaccurate Delivery 1 1
Obstruction of Flow 1 1
Misfire 1 1
Insufficient Flow or Under Infusion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 314 314
No Known Impact Or Consequence To Patient 306 306
Insufficient Information 121 121
Muscle Spasm(s) 109 109
No Consequences Or Impact To Patient 99 99
Hemorrhage/Bleeding 40 40
Fistula 34 34
No Code Available 27 27
Burn(s) 26 26
Pain 25 25
No Patient Involvement 25 25
Pneumothorax 24 24
Necrosis 20 20
No Information 19 19
Cramp(s) /Muscle Spasm(s) 18 18
Epistaxis 17 17
Hematoma 17 17
Pleural Effusion 16 16
Partial thickness (Second Degree) Burn 16 16
Renal Failure 15 15
Superficial (First Degree) Burn 14 14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 14 14
Perforation 13 13
Unspecified Infection 13 13
Laceration(s) 12 12
Burn, Thermal 11 11
Caustic/Chemical Burns 11 11
Blood Loss 11 11
Obstruction/Occlusion 10 10
Cryogenic Burn 10 12
Incontinence 10 10
Dyspnea 10 10
Injury 10 10
Arrhythmia 9 9
Respiratory Failure 9 9
Full thickness (Third Degree) Burn 9 9
Swelling/ Edema 8 8
Cardiac Arrest 8 8
Stenosis 8 8
Urinary Retention 8 8
Nerve Damage 7 7
Fatigue 7 7
Perforation of Esophagus 7 7
Hematuria 6 6
Cancer 6 6
Hemoptysis 6 6
Urinary Tract Infection 6 6
Discomfort 6 6
Air Embolism 5 5
Pseudoaneurysm 5 5
Foreign Body In Patient 4 4
Patient Problem/Medical Problem 4 4
Abdominal Distention 4 4
Electric Shock 4 4
Numbness 4 4
Loss of consciousness 4 4
Laceration(s) of Esophagus 4 4
Erectile Dysfunction 4 4
Unspecified Tissue Injury 4 4
Bradycardia 4 4
Stroke/CVA 4 4
Impotence 4 4
Inflammation 4 4
Complaint, Ill-Defined 4 4
Swelling 4 4
Internal Organ Perforation 4 4
Muscle Weakness 4 4
Myocardial Infarction 3 3
Erythema 3 3
Urethral Stenosis/Stricture 3 3
Blister 3 5
Bowel Perforation 3 3
Alteration In Body Temperature 2 2
Thromboembolism 2 2
Dizziness 2 2
Impaired Healing 2 2
Spinal Cord Injury 2 2
Paraplegia 2 2
Pericardial Effusion 2 2
Foreign Body Embolism 2 2
Gastrointestinal Hemorrhage 2 2
Urinary Incontinence 2 2
Edema 2 2
Headache 2 2
Low Blood Pressure/ Hypotension 2 2
Death 2 2
Diarrhea 2 2
Cardiomyopathy 2 2
Bacterial Infection 2 2
Abdominal Pain 2 2
Nausea 2 2
Device Overstimulation of Tissue 2 2
Neuropathy 2 2
Paralysis 2 2
Pneumonia 2 2
Vomiting 2 2
Anxiety 2 2
Therapeutic Effects, Unexpected 2 2
Tissue Damage 1 1
Peroneal Nerve Palsy 1 1

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 Galil Medical, Inc. II Nov-14-2019
6 Icecure Medical Ltd II Sep-29-2023
7 OraSure Technologies, Inc. III Sep-23-2020
8 PENTAX of America Inc II May-14-2019
9 PENTAX of America Inc II Mar-01-2019
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