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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
2018 64 64
2019 55 55
2020 171 171
2021 160 160
2022 63 63
2023 49 49

Device Problems MDRs with this Device Problem Events in those MDRs
Break 311 311
Material Separation 53 53
Detachment of Device or Device Component 39 39
Mechanical Jam 31 31
Mechanical Problem 17 17
Failure to Advance 14 14
Adverse Event Without Identified Device or Use Problem 11 11
Fracture 10 10
Physical Resistance/Sticking 9 9
Material Integrity Problem 8 8
Material Deformation 7 7
Detachment Of Device Component 7 7
Insufficient Information 6 6
Material Split, Cut or Torn 5 5
Device Dislodged or Dislocated 5 5
Device Operates Differently Than Expected 5 5
Material Fragmentation 5 5
Misassembled 5 5
Delivered as Unsterile Product 4 4
Difficult to Open or Close 4 4
Ejection Problem 4 4
Firing Problem 4 4
Device Fell 4 4
No Apparent Adverse Event 4 4
Failure to Fire 3 3
Device-Device Incompatibility 3 3
Nonstandard Device 3 3
Device Damaged Prior to Use 3 3
Bent 3 3
Positioning Failure 3 3
Entrapment of Device 3 3
Failure to Cycle 2 2
Difficult to Insert 2 2
Separation Failure 2 2
Device Contamination with Chemical or Other Material 2 2
Activation, Positioning or Separation Problem 2 2
Difficult to Open or Remove Packaging Material 2 2
Activation Problem 2 2
Separation Problem 2 2
Inaccurate Information 1 1
Appropriate Term/Code Not Available 1 1
Migration 1 1
Output Problem 1 1
Unintended Movement 1 1
Device Operational Issue 1 1
Device Disinfection Or Sterilization Issue 1 1
Installation-Related Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Twisted/Bent 1 1
Defective Device 1 1
Expiration Date Error 1 1
Misfire 1 1
Solder Joint Fracture 1 1
Failure to Align 1 1
Unsealed Device Packaging 1 1
Product Quality Problem 1 1
Retraction Problem 1 1
Problem with Sterilization 1 1
Unstable 1 1
Use of Device Problem 1 1
Loose or Intermittent Connection 1 1
Melted 1 1
Grounding Malfunction 1 1
Flaked 1 1
Difficult to Fold, Unfold or Collapse 1 1
Component Falling 1 1
Crack 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 295 295
No Known Impact Or Consequence To Patient 176 176
No Consequences Or Impact To Patient 36 36
Foreign Body In Patient 22 22
No Information 19 19
No Patient Involvement 9 9
Device Embedded In Tissue or Plaque 8 8
Insufficient Information 7 7
Injury 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Hypersensitivity/Allergic reaction 2 2
Failure of Implant 1 1
Unspecified Infection 1 1
Pain 1 1
Scar Tissue 1 1
Tissue Damage 1 1
Chills 1 1
Rupture 1 1
No Code Available 1 1

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