• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device blade, scalpel
Regulation Description Manual surgical instrument for general use.
Product CodeGES
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2016 45 45
2017 73 73
2018 80 80
2019 53 53
2020 35 35
2021 28 28

Device Problems MDRs with this Device Problem Events in those MDRs
Break 172 172
Tear, Rip or Hole in Device Packaging 31 31
Dull, Blunt 29 29
Material Integrity Problem 15 15
Mechanical Problem 13 13
Failure to Cut 12 12
Detachment Of Device Component 10 10
Device Operates Differently Than Expected 7 7
Fracture 6 6
Manufacturing, Packaging or Shipping Problem 6 6
Delivered as Unsterile Product 5 5
Difficult to Remove 5 5
Material Fragmentation 4 4
Device Packaging Compromised 4 4
Detachment of Device or Device Component 4 4
Product Quality Problem 4 4
Component Falling 4 4
Corroded 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Material Discolored 3 3
Device Damaged Prior to Use 3 3
Packaging Problem 3 3
Hole In Material 3 3
Unsealed Device Packaging 2 2
Difficult to Open or Remove Packaging Material 2 2
Device Handling Problem 2 2
Entrapment of Device 2 2
Device Disinfection Or Sterilization Issue 2 2
Difficult to Advance 1 1
Fail-Safe Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Device Contaminated During Manufacture or Shipping 1 1
Contamination /Decontamination Problem 1 1
Connection Problem 1 1
Device Contamination with Body Fluid 1 1
Inadequacy of Device Shape and/or Size 1 1
Positioning Problem 1 1
Pressure Problem 1 1
Device Fell 1 1
Material Deformation 1 1
Material Split, Cut or Torn 1 1
Protective Measures Problem 1 1
Calibration Problem 1 1
Crack 1 1
Unintended Ejection 1 1
Retraction Problem 1 1
Material Too Rigid or Stiff 1 1
Material Separation 1 1
Device Slipped 1 1
Use of Device Problem 1 1
Component Missing 1 1
Incomplete or Missing Packaging 1 1
Structural Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 98 98
Foreign Body In Patient 62 62
No Information 37 37
No Clinical Signs, Symptoms or Conditions 27 27
No Consequences Or Impact To Patient 23 23
No Patient Involvement 19 19
Injury 14 14
Laceration(s) 9 9
Insufficient Information 9 9
Device Embedded In Tissue or Plaque 8 8
No Code Available 5 5
Tissue Damage 4 4
Hemorrhage/Bleeding 1 1
Pain 1 1
Needle Stick/Puncture 1 1
Patient Problem/Medical Problem 1 1
Nervous System Injury 1 1
Sedation 1 1
Burn(s) 1 1
Inflammation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aspen Surgical Puerto Rico Corp. II Sep-08-2016
-
-