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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device passer
Product CodeHWQ
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2017 39 39
2018 64 64
2019 55 55
2020 171 171
2021 160 160
2022 63 63

Device Problems MDRs with this Device Problem Events in those MDRs
Break 298 298
Material Separation 53 53
Mechanical Jam 33 33
Detachment of Device or Device Component 30 30
Failure to Advance 17 17
Mechanical Problem 17 17
Device Operates Differently Than Expected 12 12
Adverse Event Without Identified Device or Use Problem 11 11
Physical Resistance/Sticking 9 9
Fracture 9 9
Detachment Of Device Component 9 9
Material Fragmentation 8 8
Insufficient Information 6 6
Material Deformation 6 6
Device Dislodged or Dislocated 6 6
Material Integrity Problem 5 5
Material Split, Cut or Torn 5 5
Misassembled 5 5
Delivered as Unsterile Product 4 4
Bent 4 4
Ejection Problem 4 4
Firing Problem 4 4
Device Fell 4 4
No Apparent Adverse Event 4 4
Difficult to Open or Close 4 4
Device-Device Incompatibility 3 3
Failure to Fire 3 3
Activation, Positioning or Separation Problem 3 3
Positioning Failure 3 3
Entrapment of Device 3 3
Nonstandard Device 3 3
Device Damaged Prior to Use 3 3
Unsealed Device Packaging 2 2
Component Falling 2 2
Difficult to Insert 2 2
Separation Failure 2 2
Difficult to Open or Remove Packaging Material 2 2
Device Contamination with Chemical or Other Material 2 2
Device Packaging Compromised 2 2
Separation Problem 2 2
Inaccurate Information 1 1
Appropriate Term/Code Not Available 1 1
Material Twisted/Bent 1 1
Output Problem 1 1
Unintended Movement 1 1
Installation-Related Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Difficult to Advance 1 1
Defective Device 1 1
Device Or Device Fragments Location Unknown 1 1
Device Operational Issue 1 1
Device Disinfection Or Sterilization Issue 1 1
Loose or Intermittent Connection 1 1
Melted 1 1
Migration or Expulsion of Device 1 1
Loss of or Failure to Bond 1 1
Grounding Malfunction 1 1
Crack 1 1
Failure to Cycle 1 1
Difficult or Delayed Positioning 1 1
Flaked 1 1
Difficult to Fold, Unfold or Collapse 1 1
Product Quality Problem 1 1
Difficult to Remove 1 1
Retraction Problem 1 1
Problem with Sterilization 1 1
Use of Device Problem 1 1
Metal Shedding Debris 1 1
Component Missing 1 1
Out-Of-Box Failure 1 1
Solder Joint Fracture 1 1
Failure to Align 1 1
Expiration Date Error 1 1
Misfire 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 252 252
No Known Impact Or Consequence To Patient 203 203
No Consequences Or Impact To Patient 42 42
No Information 21 21
Foreign Body In Patient 19 19
No Patient Involvement 9 9
Device Embedded In Tissue or Plaque 8 8
Insufficient Information 5 5
Injury 5 5
Hypersensitivity/Allergic reaction 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
No Code Available 2 2
Unspecified Infection 1 1
Pain 1 1
Scar Tissue 1 1
Tissue Damage 1 1
Chills 1 1
Rupture 1 1

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