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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
ATRICURE, INC.
  SUBSTANTIALLY EQUIVALENT 1
B.M. TECH. WORLDWIDE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BOVIE MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
BRYMILL CRYOGENIC SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
C2 THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CRYOCONCEPTS LP
  SUBSTANTIALLY EQUIVALENT 3
CSA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
DGI TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
ERBE ELEKTROMEDIZIN GMBH
  SUBSTANTIALLY EQUIVALENT 1
GALIL MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
GALIL MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
ICECURE MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDILINK A/S
  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
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
THE OTC LAB HEALTHCARE B.V.
  SUBSTANTIALLY EQUIVALENT 1
VARIAN MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
YOZMA BMTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 207 207
2019 455 455
2020 277 278
2021 213 214
2022 229 229

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 235 235
Appropriate Term/Code Not Available 209 209
Temperature Problem 129 129
Excessive Cooling 94 94
Defective Device 72 72
Thermal Decomposition of Device 66 66
Break 60 60
Gas/Air Leak 55 55
Therapeutic or Diagnostic Output Failure 51 51
Insufficient Cooling 50 50
Leak/Splash 47 47
Device Operates Differently Than Expected 41 41
Defective Component 30 30
Physical Resistance/Sticking 27 27
Insufficient Heating 27 27
Mechanical Problem 26 26
Output Problem 24 24
Material Twisted/Bent 20 20
Failure to Fire 14 14
Insufficient Information 14 14
Incorrect, Inadequate or Imprecise Result or Readings 13 13
Fluid/Blood Leak 12 12
Crack 10 10
Material Deformation 10 10
Material Separation 9 9
Use of Device Problem 9 9
Loose or Intermittent Connection 9 9
Device Displays Incorrect Message 9 9
Moisture or Humidity Problem 7 7
Detachment of Device or Device Component 7 7
Failure to Shut Off 7 7
Gas Output Problem 6 6
Material Rupture 6 6
Protective Measures Problem 6 6
Misconnection 6 6
Failure of Device to Self-Test 6 6
Pressure Problem 5 5
Contamination 5 5
Improper or Incorrect Procedure or Method 5 5
Mechanical Jam 5 5
Difficult to Remove 5 5
Burst Container or Vessel 5 5
Device Alarm System 5 5
Component Missing 5 5
Difficult to Open or Close 5 5
Activation Problem 5 5
Noise, Audible 4 4
Naturally Worn 4 4
No Display/Image 4 4
Difficult or Delayed Activation 4 4
Connection Problem 4 4
Disconnection 4 4
Operating System Becomes Nonfunctional 4 4
Device Handling Problem 3 3
Complete Blockage 3 3
Fire 3 3
Inflation Problem 3 3
Excess Flow or Over-Infusion 3 3
Loss of Power 3 3
Failure to Read Input Signal 3 3
Free or Unrestricted Flow 3 5
Mechanics Altered 3 3
Application Program Freezes, Becomes Nonfunctional 3 3
Display or Visual Feedback Problem 3 3
Unintended Ejection 3 3
Premature Activation 3 3
Blocked Connection 2 2
Improper Flow or Infusion 2 2
Material Split, Cut or Torn 2 2
Failure to Deflate 2 2
Contamination /Decontamination Problem 2 2
Moisture Damage 2 2
Electrical /Electronic Property Problem 2 2
Self-Activation or Keying 2 2
Device Inoperable 2 2
Corroded 2 2
Energy Output Problem 2 2
Partial Blockage 2 2
No Pressure 2 2
Failure to Power Up 2 2
Patient-Device Incompatibility 2 2
Computer Operating System Problem 2 2
Unsealed Device Packaging 2 2
Misassembly by Users 2 4
Unexpected Shutdown 1 1
Infusion or Flow Problem 1 1
Incorrect Interpretation of Signal 1 1
Material Opacification 1 1
Fracture 1 1
Incomplete or Inadequate Connection 1 1
Tear, Rip or Hole in Device Packaging 1 1
Material Integrity Problem 1 1
Device Sensing Problem 1 1
Product Quality Problem 1 1
Device Damaged Prior to Use 1 1
Misfire 1 1
Computer Software Problem 1 1
Intermittent Continuity 1 1
Malposition of Device 1 1
Key or Button Unresponsive/not Working 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 364 364
No Clinical Signs, Symptoms or Conditions 193 193
No Consequences Or Impact To Patient 159 159
Insufficient Information 118 118
Muscle Spasm(s) 116 116
Hemorrhage/Bleeding 36 36
Fistula 34 34
No Patient Involvement 31 31
No Code Available 31 31
No Information 30 30
Stenosis 24 24
Pneumothorax 24 24
Burn(s) 21 21
Necrosis 19 19
Pain 19 19
Burn, Thermal 17 17
Cramp(s) /Muscle Spasm(s) 17 17
Pleural Effusion 16 16
Hematoma 16 16
Renal Failure 15 15
Injury 15 15
Unspecified Infection 13 13
Patient Problem/Medical Problem 13 13
Blood Loss 12 12
Partial thickness (Second Degree) Burn 12 12
Laceration(s) 11 11
Incontinence 10 10
Obstruction/Occlusion 10 10
Epistaxis 10 10
Respiratory Failure 9 9
Dyspnea 9 9
Arrhythmia 9 9
Nerve Damage 9 9
Cardiac Arrest 9 9
Superficial (First Degree) Burn 9 9
Perforation 9 9
Caustic/Chemical Burns 8 8
Full thickness (Third Degree) Burn 8 8
Urinary Retention 8 8
Swelling/ Edema 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Discomfort 7 7
Perforation of Esophagus 7 7
Fatigue 6 6
Hemoptysis 6 6
Pseudoaneurysm 5 5
Urinary Tract Infection 5 5
Bradycardia 5 5
Death 5 5
Swelling 5 5
Air Embolism 5 5
Hematuria 5 5
Numbness 5 5
Cryogenic Burn 5 7
Abdominal Distention 4 4
Muscle Weakness 4 4
Complaint, Ill-Defined 4 4
Laceration(s) of Esophagus 4 4
Loss of consciousness 4 4
Impotence 4 4
Inflammation 4 4
Stroke/CVA 4 4
Electric Shock 4 4
Internal Organ Perforation 4 4
Foreign Body In Patient 4 4
Unspecified Tissue Injury 4 4
Erectile Dysfunction 4 4
Tissue Damage 3 3
Myocardial Infarction 3 3
Abdominal Pain 3 3
Bowel Perforation 3 3
Alteration In Body Temperature 3 3
Vomiting 3 3
Urethral Stenosis/Stricture 3 3
Blister 2 4
Burning Sensation 2 2
Paralysis 2 2
Diarrhea 2 2
Headache 2 2
Paraplegia 2 2
Anxiety 2 2
Impaired Healing 2 2
Neuropathy 2 2
Skin Discoloration 2 2
Hearing Impairment 2 2
Erythema 2 2
Foreign Body Embolism 2 2
Therapeutic Effects, Unexpected 2 2
Urinary Incontinence 2 2
Cardiomyopathy 2 2
Spinal Cord Injury 2 2
Ulceration 2 2
Device Overstimulation of Tissue 2 2
Edema 2 2
Bacterial Infection 2 2
Nausea 2 2
Thromboembolism 2 2
Gastrointestinal Hemorrhage 2 2
Hematemesis 1 1
Not Applicable 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Dec-22-2020
2 Boston Scientific Corporation II Oct-23-2020
3 Boston Scientific Corporation II Jul-21-2020
4 Galil Medical, Inc. II Nov-14-2019
5 OraSure Technologies, Inc. III Sep-23-2020
6 PENTAX of America Inc II May-14-2019
7 PENTAX of America Inc II Mar-01-2019
8 PENTAX of America Inc II Jun-05-2018
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