Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device culdoscope (and accessories)
Regulation Description 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
2020 35 35
2021 14 18
2022 23 23
2023 18 18
2024 32 32
2025 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 27 28
Break 18 18
Adverse Event Without Identified Device or Use Problem 13 13
Entrapment of Device 8 8
Installation-Related Problem 6 6
Melted 5 5
Material Separation 5 5
Defective Device 5 5
Use of Device Problem 5 5
Material Rupture 4 4
Inflation Problem 4 4
Improper or Incorrect Procedure or Method 3 3
Poor Quality Image 3 3
Insufficient Information 3 3
Material Fragmentation 3 3
Material Twisted/Bent 3 3
Leak/Splash 2 2
Material Split, Cut or Torn 2 2
Product Quality Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Component Missing 2 2
Thermal Decomposition of Device 2 2
Excess Flow or Over-Infusion 2 2
Loose or Intermittent Connection 1 1
Flaked 1 1
Display or Visual Feedback Problem 1 1
Overheating of Device 1 1
Appropriate Term/Code Not Available 1 1
Increase in Pressure 1 1
Fracture 1 1
Tear, Rip or Hole in Device Packaging 1 1
Material Deformation 1 1
Material Perforation 1 1
Patient Device Interaction Problem 1 1
Contamination 1 1
Material Integrity Problem 1 1
Defective Component 1 1
Smoking 1 1
Unintended Movement 1 1
Material Puncture/Hole 1 4
Crack 1 1
Output Problem 1 1
Malposition of Device 1 1
Mechanical Problem 1 1
No Display/Image 1 1
Burst Container or Vessel 1 1
Device Contaminated During Manufacture or Shipping 1 1
Fitting Problem 1 1
Device Slipped 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 63 63
Insufficient Information 17 21
Foreign Body In Patient 11 11
No Patient Involvement 11 11
Laceration(s) 11 11
No Known Impact Or Consequence To Patient 7 7
No Consequences Or Impact To Patient 5 5
Uterine Perforation 3 3
Abdominal Pain 2 2
Unspecified Infection 2 2
Abnormal Vaginal Discharge 2 2
Hemorrhage/Bleeding 2 2
Device Embedded In Tissue or Plaque 2 2
Menstrual Irregularities 1 1
Hematuria 1 1
Bowel Perforation 1 1
Perforation 1 1
Injury 1 1
Pain 1 1
Unspecified Tissue Injury 1 1
Internal Organ Perforation 1 1

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