• 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 table, operating-room, electrical
Product CodeGDC
Regulation Number 878.4960
Device Class 1

MDR Year MDR Reports MDR Events
2019 64 64
2020 253 253
2021 259 259
2022 57 57
2023 62 62
2024 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Unstable 114 114
Unintended Movement 82 82
Physical Resistance/Sticking 78 78
Positioning Failure 51 51
Positioning Problem 46 46
Leak/Splash 36 36
Overheating of Device 26 26
Battery Problem 26 26
Material Too Rigid or Stiff 23 23
Fluid/Blood Leak 22 22
Mechanical Problem 21 21
Failure to Power Up 21 21
Mechanical Jam 21 21
Noise, Audible 19 19
Decrease in Pressure 13 13
Unintended System Motion 13 13
Break 12 12
No Apparent Adverse Event 12 12
Insufficient Information 11 11
Smoking 9 9
Key or Button Unresponsive/not Working 8 8
Use of Device Problem 7 7
Self-Activation or Keying 7 7
Operating System Becomes Nonfunctional 7 7
Device Fell 6 6
Fire 6 6
Failure to Charge 6 6
Crack 5 5
Defective Component 5 5
Material Deformation 5 5
Therapeutic or Diagnostic Output Failure 5 5
Adverse Event Without Identified Device or Use Problem 4 4
Power Problem 4 4
Device Slipped 4 4
Device Emits Odor 4 4
Fracture 4 4
Electrical /Electronic Property Problem 3 3
Loss of Power 3 3
Pressure Problem 3 3
Output Problem 3 3
Appropriate Term/Code Not Available 3 3
Device Handling Problem 3 3
Failure to Align 3 3
Connection Problem 3 3
Detachment of Device or Device Component 3 3
Device Dislodged or Dislocated 2 2
Electrical Shorting 2 2
Failure of Device to Self-Test 2 2
Compatibility Problem 2 2
Sparking 2 2
Malposition of Device 2 2
Complete Loss of Power 2 2
Improper or Incorrect Procedure or Method 2 2
Loose or Intermittent Connection 2 2
Difficult or Delayed Positioning 2 2
Unintended Power Up 1 1
Collapse 1 1
Corroded 1 1
Incorrect Measurement 1 1
Loss of or Failure to Bond 1 1
Grounding Malfunction 1 1
Device Damaged Prior to Use 1 1
Incomplete or Missing Packaging 1 1
Material Separation 1 1
Device Remains Activated 1 1
Unintended Electrical Shock 1 1
Activation Problem 1 1
Unclear Information 1 1
Activation Failure 1 1
Device Difficult to Maintain 1 1
Protective Measures Problem 1 1
Difficult or Delayed Activation 1 1
Defective Device 1 1
No Pressure 1 1
Moisture or Humidity Problem 1 1
Material Integrity Problem 1 1
Charging Problem 1 1
Component or Accessory Incompatibility 1 1
Lack of Effect 1 1
Material Split, Cut or Torn 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 405 405
No Patient Involvement 121 121
No Known Impact Or Consequence To Patient 117 117
No Information 12 12
No Consequences Or Impact To Patient 10 10
Insufficient Information 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Laceration(s) 3 3
Nerve Damage 3 3
Injury 3 3
Numbness 3 3
Fall 2 2
Rupture 2 2
Abdominal Distention 2 2
Brain Injury 1 1
No Code Available 1 1
Heart Failure/Congestive Heart Failure 1 1
Hyperextension 1 1
Unspecified Tissue Injury 1 1
Irritation 1 1
Liver Laceration(s) 1 1
Wound Dehiscence 1 1
Bruise/Contusion 1 1
Burn(s) 1 1
Cellulitis 1 1
Crushing Injury 1 1
Erythema 1 1
Burn, Thermal 1 1
Electric Shock 1 1
Pain 1 1
Perforation 1 1
Swelling 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II Jul-07-2023
2 Baxter Healthcare Corporation II Nov-03-2022
3 Mizuho America, Inc. II Dec-14-2020
4 Mizuho OSI II Mar-23-2021
5 Skytron, LLC II Aug-28-2023
-
-