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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 58
Improper or Incorrect Procedure or Method 41
Off-Label Use 26
Device Reprocessing Problem 21
Mechanical Problem 19
Fumes or Vapors 18
Appropriate Term/Code Not Available 15
Use of Device Problem 14
Break 13
Use of Incorrect Control Settings 13
Leak / Splash 13
Contamination / decontamination Problem 13
Maintenance Does Not Comply To Manufacturers Recommendations 12
Crack 10
Microbial Contamination of Device 10
Device Component Or Accessory 9
Chemical Spillage 9
No Apparent Adverse Event 8
Fluid Leak 8
Chemical Problem 8
Device Contamination with Chemical or Other Material 8
Device Handling Problem 7
Contamination During Use 7
Human-Device Interface Problem 5
Facilities Issue 5
Failure to Clean Adequately 4
Failure to Disinfect 4
Endoscope 4
Connection Problem 4
Ventilation Problem in Device Environment 4
Residue After Decontamination 3
Endoscopic Accessory 3
Bacterial Filter 3
Component Falling 3
Water Purification System 3
Inadequate Filtration Process 3
Misconnection 2
Filter 2
Device Contamination With Biological Material 2
Misassembly during Maintenance / Repair 2
Electrical Shorting 2
Shipping Damage or Problem 2
Sensor 2
Flushing problem 2
Inadequate or Insufficient Training 2
Device Rinsing Issue 1
Device Displays Incorrect Message 1
Device Emits Odor 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
Circuit Failure 1
Component Missing 1
Pressure Problem 1
Unintended Electrical Shock 1
Device Sensing Problem 1
Blocked Connection 1
Power Supply 1
Function Lid 1
Printer 1
Component Incompatible 1
Temperature Sensor 1
Test Strip 1
Data Problem 1
Reservoir 1
Accessory Incompatible 1
Pump 1
Failure to Reset 1
Device Disinfection Or Sterilization Issue 1
Environmental Compatibility Problem 1
No Flow 1
Detachment Of Device Component 1
Inadequate Service 1
Defective Device 1
Total Device Problems 459

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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