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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device culdoscope (and accessories)
Product CodeHEW
Regulation Number 884.1640
Device Class 2


Premarket Reviews
ManufacturerDecision
APPLIED MEDICAL RESOURCES CORP.
  SUBSTANTIALLY EQUIVALENT 1
COOPERSURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 29 29
2020 35 35
2021 14 14
2022 23 23
2023 18 18
2024 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Break 26 26
Detachment of Device or Device Component 17 17
Melted 13 13
Entrapment of Device 8 8
Material Separation 6 6
Defective Device 5 5
Sparking 4 4
Material Fragmentation 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Material Rupture 4 4
Material Twisted/Bent 3 3
Poor Quality Image 3 3
Thermal Decomposition of Device 3 3
Improper or Incorrect Procedure or Method 3 3
Leak/Splash 2 2
Material Puncture/Hole 2 2
Product Quality Problem 2 2
Defective Component 2 2
Component Missing 2 2
Inflation Problem 2 2
Excess Flow or Over-Infusion 2 2
Insufficient Information 2 2
Material Split, Cut or Torn 2 2
Device Fell 2 2
Appropriate Term/Code Not Available 1 1
Output Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Unintended Movement 1 1
Difficult to Insert 1 1
Overheating of Device 1 1
Increase in Pressure 1 1
Burst Container or Vessel 1 1
Crack 1 1
No Display/Image 1 1
Display or Visual Feedback Problem 1 1
Flaked 1 1
Fluid/Blood Leak 1 1
Fracture 1 1
Arcing 1 1
Contamination /Decontamination Problem 1 1
Gas/Air Leak 1 1
Material Deformation 1 1
Material Integrity Problem 1 1
Loose or Intermittent Connection 1 1
Mechanical Problem 1 1
Fitting Problem 1 1
Material Perforation 1 1
Smoking 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 36 36
No Known Impact Or Consequence To Patient 32 32
Insufficient Information 15 15
No Patient Involvement 11 11
Foreign Body In Patient 9 9
Laceration(s) 7 7
No Consequences Or Impact To Patient 5 5
Device Embedded In Tissue or Plaque 4 4
Hemorrhage/Bleeding 2 2
Uterine Perforation 2 2
Abnormal Vaginal Discharge 2 2
Menstrual Irregularities 1 1
Perforation 1 1
Injury 1 1
Bowel Perforation 1 1
No Information 1 1
Unspecified Tissue Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 CooperSurgical, Inc. II May-26-2021
2 CooperSurgical, Inc. II Jul-15-2019
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