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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 4
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 2
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 3
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 93 93

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 232 232
Appropriate Term/Code Not Available 178 178
Temperature Problem 122 122
Thermal Decomposition of Device 96 96
Excessive Cooling 83 83
Defective Device 83 83
Gas/Air Leak 76 76
Insufficient Cooling 71 71
Break 62 62
Leak/Splash 55 55
Therapeutic or Diagnostic Output Failure 53 53
Mechanical Problem 52 52
Defective Component 48 48
Insufficient Heating 45 45
Insufficient Information 32 32
Physical Resistance/Sticking 26 26
Output Problem 26 26
Use of Device Problem 22 22
Material Twisted/Bent 21 21
Noise, Audible 15 15
Failure to Fire 13 13
Incorrect, Inadequate or Imprecise Result or Readings 13 13
Fluid/Blood Leak 11 11
Crack 11 11
Material Deformation 10 10
Loose or Intermittent Connection 9 9
Material Separation 9 9
Failure to Shut Off 7 7
Device Displays Incorrect Message 6 6
Improper or Incorrect Procedure or Method 6 6
Gas Output Problem 6 6
Difficult to Remove 6 6
Material Rupture 6 6
Contamination 6 6
Moisture or Humidity Problem 6 6
Device Alarm System 6 6
Explosion 6 6
Expulsion 6 6
Infusion or Flow Problem 5 5
Burst Container or Vessel 5 5
Detachment of Device or Device Component 5 5
Activation Problem 5 5
No Display/Image 5 5
Mechanical Jam 5 5
Difficult to Open or Close 5 5
Pressure Problem 5 5
Free or Unrestricted Flow 5 7
Difficult or Delayed Activation 4 4
Device Handling Problem 4 4
Fracture 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 343 343
No Known Impact Or Consequence To Patient 306 306
Insufficient Information 124 124
Muscle Spasm(s) 109 109
No Consequences Or Impact To Patient 99 99
Hemorrhage/Bleeding 43 43
Fistula 34 34
Burn(s) 34 34
Pain 29 29
No Code Available 27 27
Pneumothorax 26 26
No Patient Involvement 25 25
Necrosis 20 20
No Information 19 19
Cramp(s) /Muscle Spasm(s) 18 18
Hematoma 17 17
Epistaxis 17 17
Pleural Effusion 16 16
Partial thickness (Second Degree) Burn 16 16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 15 15
Renal Failure 15 15
Superficial (First Degree) Burn 15 15
Cryogenic Burn 14 16
Perforation 13 13
Unspecified Infection 13 13
Laceration(s) 12 12
Caustic/Chemical Burns 11 11
Burn, Thermal 11 11
Blood Loss 11 11
Full thickness (Third Degree) Burn 10 10
Injury 10 10
Incontinence 10 10
Obstruction/Occlusion 10 10
Dyspnea 10 10
Arrhythmia 9 9
Respiratory Failure 9 9
Urinary Retention 8 8
Swelling/ Edema 8 8
Stenosis 8 8
Cardiac Arrest 8 8
Fatigue 7 7
Perforation of Esophagus 7 7
Nerve Damage 7 7
Cancer 6 6
Hematuria 6 6
Hemoptysis 6 6
Discomfort 6 6
Urinary Tract Infection 6 6
Foreign Body In Patient 5 5
Pseudoaneurysm 5 5

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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