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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 table, operating-room, ac-powered
Product CodeFQO
Regulation Number 878.4960
Device Class 1


Premarket Reviews
ManufacturerDecision
MOON SURGICAL
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2019 118 118
2020 97 97
2021 102 102
2022 125 125
2023 191 191
2024 106 106

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Movement 163 163
Use of Device Problem 95 95
Positioning Failure 64 64
Detachment of Device or Device Component 58 58
Insufficient Information 49 49
Mechanical Problem 30 30
Improper or Incorrect Procedure or Method 29 29
Positioning Problem 26 26
Device Fell 26 26
Electromagnetic Interference 23 23
Adverse Event Without Identified Device or Use Problem 22 22
Device Tipped Over 21 21
Unintended System Motion 20 20
Smoking 19 19
Communication or Transmission Problem 19 19
Fluid/Blood Leak 18 18
Device Sensing Problem 16 16
Circuit Failure 16 16
Break 14 14
Battery Problem 13 13
No Apparent Adverse Event 12 12
Device Handling Problem 11 11
Electrical Shorting 8 8
Difficult or Delayed Positioning 8 8
Structural Problem 7 7
Sharp Edges 7 7
Self-Activation or Keying 7 7
Fire 7 7
Naturally Worn 7 7
Key or Button Unresponsive/not Working 7 7
Noise, Audible 6 6
Unintended Collision 6 6
Sparking 6 6
Disconnection 6 6
Electrical /Electronic Property Problem 6 6
Device Slipped 6 6
Device Emits Odor 6 6
Complete Loss of Power 6 6
Fracture 6 6
Charging Problem 6 6
Patient Device Interaction Problem 6 6
Material Split, Cut or Torn 5 5
Intermittent Communication Failure 5 5
Physical Resistance/Sticking 5 5
Overheating of Device 5 5
Therapeutic or Diagnostic Output Failure 5 5
Moisture Damage 5 5
Mechanical Jam 4 4
Loose or Intermittent Connection 4 4
Power Problem 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 425 425
No Known Impact Or Consequence To Patient 69 69
Insufficient Information 48 48
No Consequences Or Impact To Patient 46 46
Laceration(s) 30 30
Injury 26 26
Fall 19 19
Bone Fracture(s) 16 16
Electric Shock 11 11
Abrasion 11 11
Pain 8 8
No Information 7 7
Unspecified Tissue Injury 6 6
Limb Fracture 6 6
Head Injury 6 6
Bruise/Contusion 5 5
Burn(s) 5 5
Crushing Injury 5 5
No Code Available 5 5
Death 5 5
Localized Skin Lesion 3 3
No Patient Involvement 3 3
Hematoma 3 3
Hyperextension 3 3
Tooth Fracture 2 2
Cardiac Arrest 2 2
Multiple Fractures 2 2
Muscle Weakness 2 2
Nerve Damage 2 2
Discomfort 2 2
Unspecified Musculoskeletal problem 2 2
Nausea 2 2
Ulcer 2 2
Skin Tears 2 2
Low Blood Pressure/ Hypotension 2 2
Edema 1 1
Hematuria 1 1
Tissue Damage 1 1
Hemorrhage/Bleeding 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Patient Problem/Medical Problem 1 1
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Getinge Group Logistics America, LLC II Mar-23-2021
2 Getinge Usa Sales Inc II Jul-05-2024
3 Getinge Usa Sales Inc II Oct-04-2023
4 Getinge Usa Sales Inc II Nov-15-2022
5 IHB OPERATIONS B.V. II Dec-01-2023
6 Maquet Cardiovascular Us Sales, Llc II Oct-20-2020
7 Skytron, Div. The KMW Group, Inc II Jun-30-2022
8 Skytron, Div. The KMW Group, Inc II Jun-15-2021
9 Skytron, Div. The KMW Group, Inc II Mar-25-2020
10 Stryker Communications II Mar-24-2021
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