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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device washer, cleaner, automated, endoscope
Definition This automated device is intended to be used to clean endoscopes. Endoscopes that are intended to be cleaned by the automated cleaner system should have been pre-cleaned and tested for leaks and lumen obstructions according to the instrument manufacturer's instructions and current professional practices prior to processing in the system. The system includes a chemical dispensing system that meters out a predetermined volume of detergent during the appropriate cleaning cycle. 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). The instrument is placed in a tray with each lumen end positioned in opposite sides of the tray to allow enough detergent and rinsing water pass through the lumens of the endoscopes.
Product CodeNVE
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
STERIS
  SUBSTANTIALLY EQUIVALENT 2
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2019 4 4
2020 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Improper or Incorrect Procedure or Method 2 2
Residue After Decontamination 1 1
Obstruction of Flow 1 1
Fumes or Vapors 1 1
Device Contamination with Chemical or Other Material 1 1
Pumping Problem 1 1
Complete Blockage 1 1
Use of Incorrect Control/Treatment Settings 1 1
Failure to Disinfect 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 5 5
Chemical Exposure 1 1

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