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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device accessories, cleaning, for endoscope
Regulation Description Endoscope and accessories.
Definition If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Product CodeFEB
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
CUSTOM ULTRASONICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Adverse Event Without Identified Device or Use Problem 73
Improper or Incorrect Procedure or Method 42
Break 41
Device Reprocessing Problem 33
Mechanical Problem 27
Crack 26
Off-Label Use 26
Use of Device Problem 19
Fumes or Vapors 18
Appropriate Term/Code Not Available 15
Microbial Contamination of Device 15
Use of Incorrect Control Settings 13
Leak/Splash 13
Contamination /Decontamination Problem 13
Maintenance Does Not Comply To Manufacturers Recommendations 12
Device Contamination with Chemical or Other Material 10
Fluid Leak 10
Device Component Or Accessory 9
Chemical Spillage 9
No Apparent Adverse Event 8
Chemical Problem 8
Device Handling Problem 8
Contamination 7
Connection Problem 6
Component Missing 5
Human-Device Interface Problem 5
Failure to Clean Adequately 5
Failure to Disinfect 5
Facilities Issue 5
Ventilation Problem in Device Environment 4
Endoscope 4
Residue After Decontamination 3
Water Purification System 3
Inadequate Filtration Process 3
Endoscopic Accessory 3
Bacterial Filter 3
Component Falling 3
Device Contamination With Biological Material 2
Misassembly During Maintenance/Repair 2
Filter 2
Misconnection 2
Defective Device 2
Electrical Shorting 2
Shipping Damage or Problem 2
Sensor 2
Electrical /Electronic Property Problem 2
Flushing Problem 2
Inadequate or Insufficient Training 2
Defective Component 1
Device Rinsing Issue 1
Obstruction of Flow 1
Device Displays Incorrect Message 1
Detachment of Device or Device Component 1
Device Emits Odor 1
Disconnection 1
Display Difficult to Read 1
Device Misassembled During Manufacturing /Shipping 1
Device Unsafe to Use in Environment 1
Mechanics Altered 1
Filtration Problem 1
Contamination of Device Ingredient or Reagent 1
Loss of Data 1
Loose or Intermittent Connection 1
Circuit Failure 1
Pressure Problem 1
Detachment Of Device Component 1
Inadequate Service 1
Fitting Problem 1
Failure to Reset 1
Smoking 1
Pump 1
Device Disinfection Or Sterilization Issue 1
Environmental Compatibility Problem 1
No Flow 1
Unintended Electrical Shock 1
Device Sensing Problem 1
Blocked Connection 1
Power Supply 1
Function Lid 1
Printer 1
Device Alarm System 1
Component Incompatible 1
Image Display Error/Artifact 1
Temperature Sensor 1
Test Strip 1
Data Problem 1
Reservoir 1
Accessory Incompatible 1
Total Device Problems 574

Recalls
Manufacturer Recall Class Date Posted
1 Advanced Sterilization Products II Jan-09-2017
2 Advanced Sterilization Products II Jun-05-2015
3 Olympus Corporation of the Americas II Oct-19-2016

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