• 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 cannula, surgical, general & plastic surgery
Regulation Description Manual surgical instrument for general use.
Product CodeGEA
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2020 158 158
2021 149 149
2022 83 83
2023 74 76
2024 99 99
2025 29 29

Device Problems MDRs with this Device Problem Events in those MDRs
Break 120 120
Device Markings/Labelling Problem 114 114
Device-Device Incompatibility 100 100
Delivered as Unsterile Product 52 52
Adverse Event Without Identified Device or Use Problem 37 37
Material Deformation 36 36
Crack 29 29
Material Twisted/Bent 22 22
Detachment of Device or Device Component 16 16
Fluid/Blood Leak 14 14
Material Separation 14 14
Mechanical Jam 12 12
Entrapment of Device 11 11
Material Integrity Problem 8 8
Contamination /Decontamination Problem 8 8
Packaging Problem 8 8
Device Contaminated During Manufacture or Shipping 4 4
Material Fragmentation 4 4
Contamination 3 3
Fracture 3 3
Device Slipped 2 2
Improper or Incorrect Procedure or Method 2 2
Defective Component 2 2
Use of Device Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Product Quality Problem 2 2
Dull, Blunt 1 1
Difficult to Open or Close 1 1
Complete Loss of Power 1 1
Connection Problem 1 1
Nonstandard Device 1 1
Appropriate Term/Code Not Available 1 1
Protective Measures Problem 1 1
Missing Information 1 1
Component Misassembled 1 1
No Apparent Adverse Event 1 1
Misassembly by Users 1 1
Solder Joint Fracture 1 1
Material Rupture 1 1
Misassembled 1 1
Structural Problem 1 1
Positioning Failure 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Defective Device 1 3
Material Puncture/Hole 1 1
Material Erosion 1 1
Device Damaged Prior to Use 1 1
Mechanical Problem 1 1
Burst Container or Vessel 1 1
Component or Accessory Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 385 387
No Consequences Or Impact To Patient 133 133
Insufficient Information 24 24
Foreign Body In Patient 20 20
Abscess 7 7
Pain 7 7
Unspecified Infection 5 5
Hemorrhage/Bleeding 5 5
Device Embedded In Tissue or Plaque 4 4
No Patient Involvement 4 4
Hernia 4 4
Obstruction/Occlusion 4 4
Needle Stick/Puncture 4 4
Fistula 3 3
Wound Dehiscence 3 3
Failure to Anastomose 3 3
No Code Available 3 3
Inflammation 3 3
Pleural Effusion 3 3
Cardiac Tamponade 3 3
Post Operative Wound Infection 3 3
No Known Impact Or Consequence To Patient 3 3
Fever 2 2
Peritonitis 2 2
Blood Loss 2 2
Not Applicable 2 2
Abdominal Pain 2 2
Seroma 1 1
Incontinence 1 1
Vomiting 1 1
Perforation 1 1
Discomfort 1 1
Hematoma 1 1
Adhesion(s) 1 1
Sepsis 1 1
Nausea 1 1
Unspecified Tissue Injury 1 1
Swelling/ Edema 1 1
Pneumothorax 1 1
Ectopic Pregnancy 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Unintended Radiation Exposure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 CLINICAL LASERTHERMIA SYSTEMS AB II Jun-04-2021
2 Cardinal Health 200, LLC II Mar-09-2020
3 Genicon, Inc. II Jun-05-2020
4 Sklar Instruments II Jan-16-2025
5 TeDan Surgical Innovations LLC II May-01-2020
-
-