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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

Device Problems MDRs with this Device Problem Events in those MDRs
Break 282 282
Material Separation 53 53
Mechanical Jam 31 31
Detachment of Device or Device Component 29 29
Mechanical Problem 17 17
Failure to Advance 14 14
Adverse Event Without Identified Device or Use Problem 11 11
Physical Resistance/Sticking 9 9
Detachment Of Device Component 7 7
Fracture 7 7
Material Deformation 6 6
Insufficient Information 6 6
Device Dislodged or Dislocated 5 5
Material Split, Cut or Torn 5 5
Misassembled 5 5
Material Integrity Problem 5 5
Material Fragmentation 5 5
Device Operates Differently Than Expected 5 5
Device Fell 4 4
Delivered as Unsterile Product 4 4
Firing Problem 4 4
Ejection Problem 4 4
Difficult to Open or Close 4 4
No Apparent Adverse Event 4 4
Nonstandard Device 3 3
Device Damaged Prior to Use 3 3
Entrapment of Device 3 3
Failure to Fire 3 3
Device-Device Incompatibility 3 3
Bent 3 3
Positioning Failure 3 3
Separation Failure 2 2
Device Contamination with Chemical or Other Material 2 2
Difficult to Insert 2 2
Activation, Positioning or Separation Problem 2 2
Difficult to Open or Remove Packaging Material 2 2
Separation Problem 2 2
Output Problem 1 1
Appropriate Term/Code Not Available 1 1
Retraction Problem 1 1
Use of Device Problem 1 1
Failure to Align 1 1
Defective Device 1 1
Melted 1 1
Crack 1 1
Loose or Intermittent Connection 1 1
Flaked 1 1
Grounding Malfunction 1 1
Misfire 1 1
Device Disinfection Or Sterilization Issue 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Component Falling 1 1
Difficult to Fold, Unfold or Collapse 1 1
Product Quality Problem 1 1
Solder Joint Fracture 1 1
Unintended Movement 1 1
Problem with Sterilization 1 1
Expiration Date Error 1 1
Failure to Cycle 1 1
Unsealed Device Packaging 1 1
Device Operational Issue 1 1
Installation-Related Problem 1 1
Material Twisted/Bent 1 1
Inaccurate Information 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 176 176
No Consequences Or Impact To Patient 36 36
No Information 19 19
Foreign Body In Patient 18 18
No Patient Involvement 9 9
Device Embedded In Tissue or Plaque 6 6
Injury 5 5
Insufficient Information 5 5
Hypersensitivity/Allergic reaction 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Chills 1 1
Tissue Damage 1 1
No Code Available 1 1
Rupture 1 1
Unspecified Infection 1 1
Pain 1 1
Scar Tissue 1 1

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