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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
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 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 2
CRY IQ AB
  SUBSTANTIALLY EQUIVALENT 1
CRYOCONCEPTS LP
  SUBSTANTIALLY EQUIVALENT 4
CRYOFOS MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
CSA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 5
DGI TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
ERBE ELEKTROMEDIZIN GMBH
  SUBSTANTIALLY EQUIVALENT 1
GALIL MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 3
GALIL MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
ICECURE MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDILINK A/S
  SUBSTANTIALLY EQUIVALENT 1
MEDTECH PRODUCTS INC.
  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 DERMATOLOGY ,INC
  SUBSTANTIALLY EQUIVALENT 1
R2 TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
RECENS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
RECENSMEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
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
2017 216 216
2018 207 207
2019 455 455
2020 277 278
2021 213 214
2022 162 162

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 253 253
Appropriate Term/Code Not Available 208 208
Device Operates Differently Than Expected 179 179
Temperature Problem 132 132
Excessive Cooling 106 106
Defective Device 72 72
Break 60 60
Thermal Decomposition of Device 58 58
Gas Leak 55 55
Therapeutic or Diagnostic Output Failure 51 51
Leak/Splash 48 48
Insufficient Cooling 41 41
Physical Resistance/Sticking 27 27
Output Problem 24 24
Insufficient Heating 23 23
Mechanical Problem 23 23
Material Twisted/Bent 21 21
Failure to Fire 16 16
Insufficient Information 14 14
Incorrect, Inadequate or Imprecise Resultor Readings 13 13
Fluid Leak 12 12
Defective Component 11 11
Device Displays Incorrect Message 11 11
Material Separation 10 10
Crack 10 10
Material Deformation 10 10
Loose or Intermittent Connection 9 9
Use of Device Problem 8 8
Device Operational Issue 7 7
Detachment of Device or Device Component 7 7
Gas Output Problem 7 7
Moisture or Humidity Problem 7 7
Failure to Shut Off 7 7
Protective Measures Problem 7 7
Difficult to Open or Close 6 6
Failure of Device to Self-Test 6 6
Fire 6 6
Misconnection 6 6
Burst Container or Vessel 6 6
Connection Problem 6 6
Improper or Incorrect Procedure or Method 5 5
Component Missing 5 5
Device Alarm System 5 5
Contamination 5 5
No Display/Image 5 5
Loss of Power 5 5
Mechanical Jam 5 5
Mechanics Altered 5 5
Activation Problem 5 5
Noise, Audible 4 4
Naturally Worn 4 4
Operating System Becomes Nonfunctional 4 4
Pressure Problem 4 4
No Apparent Adverse Event 4 4
Disconnection 4 4
Difficult to Remove 4 4
Material Rupture 4 4
Difficult or Delayed Activation 4 4
Failure to Read Input Signal 3 3
Premature Activation 3 3
Unintended Ejection 3 3
Display or Visual Feedback Problem 3 3
Complete Blockage 3 3
Inflation Problem 3 3
Excess Flow or Over-Infusion 3 3
Device Handling Problem 3 3
Free or Unrestricted Flow 3 5
Application Program Freezes, Becomes Nonfunctional 3 3
Failure to Deflate 2 2
Material Split, Cut or Torn 2 2
Improper Flow or Infusion 2 2
Misassembly by Users 2 4
No Pressure 2 2
Energy Output Problem 2 2
Unsealed Device Packaging 2 2
Moisture Damage 2 2
Partial Blockage 2 2
Electrical /Electronic Property Problem 2 2
Application Interface Becomes Non-Functional Or Program Exits Abnormally 2 2
Corroded 2 2
Self-Activation or Keying 2 2
Device Inoperable 2 2
Device Sensing Problem 2 2
Patient-Device Incompatibility 2 2
Blocked Connection 2 2
Contamination /Decontamination Problem 2 2
Computer Operating System Problem 2 2
Malposition of Device 1 1
Expulsion 1 1
Activation, Positioning or SeparationProblem 1 1
Device Damaged Prior to Use 1 1
Inaccurate Delivery 1 1
Tear, Rip or Hole in Device Packaging 1 1
Obstruction of Flow 1 1
Incorrect Or Inadequate Test Results 1 1
Misfire 1 1
Sticking 1 1
Material Puncture/Hole 1 1
Product Quality Problem 1 1
Incorrect Interpretation of Signal 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 406 406
No Consequences Or Impact To Patient 281 281
No Clinical Signs, Symptoms or Conditions 149 149
Insufficient Information 117 117
Muscle Spasm(s) 117 117
Hemorrhage/Bleeding 37 37
Fistula 35 35
No Code Available 35 35
No Information 34 34
Stenosis 34 34
No Patient Involvement 32 32
Pneumothorax 26 26
Burn, Thermal 25 25
Necrosis 19 19
Pain 19 19
Pleural Effusion 18 18
Burn(s) 18 18
Hematoma 17 17
Cramp(s) /Muscle Spasm(s) 17 17
Injury 15 15
Renal Failure 15 15
Unspecified Infection 14 14
Patient Problem/Medical Problem 14 14
Blood Loss 13 13
Laceration(s) 12 12
Incontinence 10 10
Obstruction/Occlusion 10 10
Partial thickness (Second Degree) Burn 10 10
Full thickness (Third Degree) Burn 9 9
Superficial (First Degree) Burn 9 9
Respiratory Failure 9 9
Nerve Damage 9 9
Dyspnea 9 9
Cardiac Arrest 9 9
Arrhythmia 9 9
Death 8 8
Perforation 8 8
Caustic/Chemical Burns 8 8
Perforation of Esophagus 8 8
Swelling/ Edema 8 8
Discomfort 7 7
Urinary Retention 7 7
Dysphagia/ Odynophagia 7 7
Hemoptysis 6 6
Fatigue 6 6
Bradycardia 6 6
Swelling 6 6
Numbness 6 6
Hematuria 5 5
Pseudoaneurysm 5 5
Loss of consciousness 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Cryogenic Burn 5 7
Urinary Tract Infection 5 5
Vomiting 5 5
Muscle Weakness 5 5
Air Embolism 5 5
Abdominal Pain 4 4
Impotence 4 4
Stroke/CVA 4 4
Inflammation 4 4
Internal Organ Perforation 4 4
Unspecified Tissue Injury 4 4
Erectile Dysfunction 4 4
Epistaxis 4 4
Foreign Body In Patient 4 4
Abdominal Distention 4 4
Electric Shock 4 4
Complaint, Ill-Defined 4 4
Laceration(s) of Esophagus 3 3
Alteration In Body Temperature 3 3
Bowel Perforation 3 3
Urethral Stenosis/Stricture 3 3
Paralysis 3 3
Myocardial Infarction 3 3
Tissue Damage 3 3
Skin Irritation 3 3
Erythema 3 3
Edema 2 2
Headache 2 2
Hearing Impairment 2 2
Bacterial Infection 2 2
Diarrhea 2 2
Cardiomyopathy 2 2
Cardiopulmonary Arrest 2 2
Cellulitis 2 2
Seizures 2 2
Skin Discoloration 2 2
Ulceration 2 2
Burning Sensation 2 2
Nausea 2 2
Device Overstimulation of Tissue 2 2
Neuropathy 2 2
Foreign Body Embolism 2 2
Blister 2 4
Gastrointestinal Hemorrhage 2 2
Urinary Incontinence 2 2
Thromboembolism 2 2
Not Applicable 2 2
Therapeutic Effects, Unexpected 2 2

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 C2 Therapeutics, Inc. II Mar-15-2017
5 Galil Medical, Inc. II Nov-14-2019
6 OraSure Technologies, Inc. III Sep-23-2020
7 PENTAX of America Inc II May-14-2019
8 PENTAX of America Inc II Mar-01-2019
9 PENTAX of America Inc II Jun-05-2018
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