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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device endoscopic access overtube, gastroenterology-urology
Regulation Description Endoscope and accessories.
Definition To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation.
Product CodeFED
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
BODDINGTONS PLASTICS LTD
  SUBSTANTIALLY EQUIVALENT 3
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
C2 THERAPEUTICS
  SUBSTANTIALLY EQUIVALENT 1
COLOPLAST MANUFACTURING US LLC
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDIVATORS REPROCESSING SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
MEDIVATORS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICRO-TECH (NAN JING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VISIONSENSE LTD.
  SUBSTANTIALLY EQUIVALENT 1
WELL LEAD MEDICAL CO. LTD
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Shaft 25
Peeled/Delaminated 15
Adverse Event Without Identified Device or Use Problem 14
Torn Material 12
Misassembled 7
Break 7
Material Split, Cut or Torn 6
Fracture 5
Device Contamination with Chemical or Other Material 5
Flaked 4
Detachment Of Device Component 4
Partial Blockage 3
Material Integrity Problem 3
Patient-Device Incompatibility 3
Material Separation 3
Insufficient Information 3
Appropriate Term/Code Not Available 2
Use of Device Problem 2
Contamination /Decontamination Problem 2
Detachment of Device or Device Component 2
Inflation Problem 2
Difficult to Insert 1
Nonstandard Device 1
Material Fragmentation 1
Crack 1
Deflation Problem 1
Balloon 1
Seal 1
Guidewire 1
Guide 1
Device Operates Differently Than Expected 1
Device Damaged by Another Device 1
Device Packaging Compromised 1
Difficult to Advance 1
Device Contaminated During Manufacture or Shipping 1
Material Deformation 1
Delamination 1
Difficult to Remove 1
Retraction Problem 1
Device Damaged Prior to Use 1
Microbial Contamination of Device 1
Device Handling Problem 1
Physical Resistance/Sticking 1
Packaging Problem 1
Total Device Problems 152

Recalls
Manufacturer Recall Class Date Posted
1 Boddingtons Plastics Ltd II Apr-16-2020

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