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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Unstable 117 117
Unintended Movement 87 87
Physical Resistance/Sticking 78 78
Positioning Failure 51 51
Positioning Problem 47 47
Leak/Splash 37 37
Overheating of Device 28 28
Battery Problem 26 26
Material Too Rigid or Stiff 23 23
Fluid/Blood Leak 22 22
Mechanical Problem 21 21
Mechanical Jam 21 21
Failure to Power Up 21 21
Noise, Audible 20 20
Unintended System Motion 14 14
No Apparent Adverse Event 14 14
Decrease in Pressure 13 13
Break 12 12
Insufficient Information 11 11
Smoking 9 9
Key or Button Unresponsive/not Working 9 9
Operating System Becomes Nonfunctional 8 8
Self-Activation or Keying 7 7
Use of Device Problem 7 7
Failure to Charge 6 6
Fire 6 6
Device Fell 6 6
Defective Component 5 5
Therapeutic or Diagnostic Output Failure 5 5
Crack 5 5
Material Deformation 5 5
Device Emits Odor 4 4
Device Slipped 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Power Problem 4 4
Fracture 4 4
Electrical /Electronic Property Problem 3 3
Difficult or Delayed Positioning 3 3
Connection Problem 3 3
Appropriate Term/Code Not Available 3 3
Detachment of Device or Device Component 3 3
Failure to Align 3 3
Output Problem 3 3
Loss of Power 3 3
Device Handling Problem 3 3
Pressure Problem 3 3
Failure of Device to Self-Test 2 2
Electrical Shorting 2 2
Complete Loss of Power 2 2
Malposition of Device 2 2
Loose or Intermittent Connection 2 2
Device Dislodged or Dislocated 2 2
Sparking 2 2
Improper or Incorrect Procedure or Method 2 2
Compatibility Problem 2 2
Corroded 1 1
Charging Problem 1 1
Material Integrity Problem 1 1
Unintended Electrical Shock 1 1
Activation Problem 1 1
Incorrect Measurement 1 1
Material Split, Cut or Torn 1 1
Loss of or Failure to Bond 1 1
Lack of Effect 1 1
Activation Failure 1 1
Device Difficult to Maintain 1 1
Unintended Power Up 1 1
Device Remains Activated 1 1
Device Damaged Prior to Use 1 1
Moisture or Humidity Problem 1 1
Grounding Malfunction 1 1
Difficult or Delayed Activation 1 1
Collapse 1 1
Defective Device 1 1
No Pressure 1 1
Component or Accessory Incompatibility 1 1
Protective Measures Problem 1 1
Material Separation 1 1
Incomplete or Missing Packaging 1 1
Unclear Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 415 415
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
Bone Fracture(s) 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
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