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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device sterilization wrap containers, trays, cassettes & other accessories
Regulation Description Sterilization wrap.
Product CodeKCT
Regulation Number 880.6850
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVANCED STERILIZATION PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
AESCULAP
  SUBSTANTIALLY EQUIVALENT 9
AESCULAP, INC.
  SUBSTANTIALLY EQUIVALENT 8
ANTHOGYR
  SUBSTANTIALLY EQUIVALENT 1
ARGON MED. PRODUCTIONS VERTRIEBS GESELLSCHAFT MBH CO KG
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH 200, LLC
  SUBSTANTIALLY EQUIVALENT 2
CONMED
  SUBSTANTIALLY EQUIVALENT 1
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 2
HOLOGIC, INC
  SUBSTANTIALLY EQUIVALENT 1
HOLOGIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
IMPLANT DIRECT SYBRON MANUFACTURING, LLC
  SUBSTANTIALLY EQUIVALENT 1
INSTITUT STRAUMANN AG
  SUBSTANTIALLY EQUIVALENT 2
INTUITIVE SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 5
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
MICROLINE SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
NEOTRACT, INC.
  SUBSTANTIALLY EQUIVALENT 1
NOBEL BIOCARE
  SUBSTANTIALLY EQUIVALENT 3
NOBEL BIOCARE AB
  SUBSTANTIALLY EQUIVALENT 3
NUVASIVE, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
OSUNG MND CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
PARAGON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PMBS, LLC
  SUBSTANTIALLY EQUIVALENT 2
SCICAN LTD.
  SUBSTANTIALLY EQUIVALENT 1
SOADCO, S.L.
  SUBSTANTIALLY EQUIVALENT 1
STERILUCENT, INC
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
STRAUMANN
  SUBSTANTIALLY EQUIVALENT 2
SUMMIT MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
SYBRON
  SUBSTANTIALLY EQUIVALENT 1
SYMMETRY SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
THINK SURGICAL INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 6 6
2016 16 16
2017 3 3
2018 22 22
2019 14 14
2020 60 60

Device Problems MDRs with this Device Problem Events in those MDRs
Material Integrity Problem 66 66
Crack 11 11
Device Operates Differently Than Expected 11 11
Material Puncture/Hole 5 5
Material Discolored 4 4
Flaked 3 3
Defective Component 3 3
Defective Device 3 3
Hole In Material 3 3
Break 2 2
Device Reprocessing Problem 2 2
Material Fragmentation 2 2
Material Perforation 2 2
Smoking 2 2
Appropriate Term/Code Not Available 2 2
Corroded 2 2
Device Damaged Prior to Use 2 2
Indicator 1 1
Lock 1 1
Thermal Decomposition of Device 1 1
Loose or Intermittent Connection 1 1
Delivered as Unsterile Product 1 1
Improper or Incorrect Procedure or Method 1 1
Contamination /Decontamination Problem 1 1
Device Markings/Labelling Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Device Contaminated During Manufacture or Shipping 1 1
Moisture or Humidity Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Mechanism 1 1
Sharp Edges 1 1
Difficult to Open or Close 1 1
Difficult to Open or Remove Packaging Material 1 1
Lack of Maintenance Documentation or Guidelines 1 1
Protective Measures Problem 1 1
Locking Mechanism 1 1
Tip 1 1
Use of Device Problem 1 1
Metal Shedding Debris 1 1
Material Separation 1 1
Split 1 1
Mechanical Problem 1 1
Loss of Power 1 1
Degraded 1 1
Material Disintegration 1 1
Fire 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 77 77
No Patient Involvement 29 29
No Consequences Or Impact To Patient 5 5
No Information 3 3
No Code Available 2 2
Foreign Body In Patient 1 1
Laceration(s) 1 1
Injury 1 1
Chemical Exposure 1 1
Blood Loss 1 1
Sprain 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap Implant Systems LLC II Feb-15-2018
2 Innovative Sterlization Technologies LLC II Oct-22-2015
3 Intuitive Surgical, Inc. II Jun-09-2020
4 PMBS, LLC II Mar-25-2016
5 Symmetry Surgical, Inc. II Jan-11-2017
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