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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
BIBAWO MEDICAL A/S
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BRYMILL CRYOGENIC SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
CRYOCONCEPTS LP
  SUBSTANTIALLY EQUIVALENT 3
CRYOSURGERY, INC.
  SUBSTANTIALLY EQUIVALENT 2
CSA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
DGI TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
ENDOCISION TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 1
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
MEDTECH PRODUCTS INC.
  SUBSTANTIALLY EQUIVALENT 1
NUANCE MEDICAL, LLC
  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
2020 277 278
2021 213 214
2022 230 230
2023 164 164
2024 141 144

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 205 205
Thermal Decomposition of Device 104 104
Appropriate Term/Code Not Available 86 86
Gas/Air Leak 78 78
Defective Device 77 77
Insufficient Cooling 73 73
Break 55 55
Mechanical Problem 52 52
Leak/Splash 48 48
Defective Component 45 45
Insufficient Heating 39 39
Insufficient Information 31 31
Output Problem 25 25
Use of Device Problem 24 24
Physical Resistance/Sticking 18 18
Material Twisted/Bent 18 18
Temperature Problem 18 18
Noise, Audible 15 15
Therapeutic or Diagnostic Output Failure 14 14
Failure to Fire 13 13
Crack 11 11
Loose or Intermittent Connection 9 9
Material Separation 9 9
Explosion 8 8
Improper or Incorrect Procedure or Method 8 8
Fluid/Blood Leak 8 8
Gas Output Problem 6 6
Device Alarm System 6 6
Free or Unrestricted Flow 6 11
Contamination 6 6
Difficult to Remove 6 6
Material Deformation 6 6
Expulsion 6 6
Burst Container or Vessel 5 5
Pressure Problem 5 5
Difficult to Open or Close 4 4
Naturally Worn 4 4
Fracture 4 4
No Apparent Adverse Event 4 4
Mechanical Jam 4 4
Device Handling Problem 4 4
Material Rupture 4 4
Infusion or Flow Problem 4 4
Failure to Shut Off 4 4
No Display/Image 4 4
Fire 4 4
Excessive Cooling 4 4
No Pressure 3 3
Component Missing 3 3
Premature Activation 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 368 371
Insufficient Information 124 124
Muscle Spasm(s) 71 71
No Consequences Or Impact To Patient 59 59
Hemorrhage/Bleeding 40 40
No Known Impact Or Consequence To Patient 39 39
Burn(s) 38 38
Fistula 32 32
Pain 28 28
Pneumothorax 25 25
Necrosis 19 19
Cramp(s) /Muscle Spasm(s) 18 18
Epistaxis 18 18
Superficial (First Degree) Burn 17 17
Partial thickness (Second Degree) Burn 17 17
No Code Available 16 16
Hematoma 16 16
Pleural Effusion 16 16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 15 15
Cryogenic Burn 15 17
Renal Failure 14 14
Laceration(s) 13 13
Unspecified Infection 12 12
Blood Loss 10 10
Obstruction/Occlusion 10 10
Incontinence 10 10
Perforation 10 10
Dyspnea 10 10
Full thickness (Third Degree) Burn 10 10
Arrhythmia 9 9
Respiratory Failure 9 9
Urinary Retention 8 8
Swelling/ Edema 8 8
Cardiac Arrest 8 8
Caustic/Chemical Burns 8 8
Hematuria 7 7
Discomfort 7 7
Fatigue 7 7
Nerve Damage 6 6
Foreign Body In Patient 6 6
Urinary Tract Infection 6 6
Hemoptysis 6 6
Air Embolism 5 5
Stroke/CVA 5 5
Blister 5 7
Pseudoaneurysm 5 5
Bowel Perforation 5 5
Abdominal Distention 5 5
Cancer 5 5
Impotence 4 4

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 Icecure Medical Ltd II Sep-29-2023
6 OraSure Technologies, Inc. III Sep-23-2020
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