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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cystourethroscope
Regulation Description Endoscope and accessories.
Product CodeFBO
Regulation Number 876.1500
Device Class 2

MDR Year MDR Reports MDR Events
2016 9 9
2017 11 11
2018 11 11
2019 15 15
2020 20 20
2021 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 18 18
Break 12 12
Contamination /Decontamination Problem 11 11
Material Fragmentation 6 6
Sparking 6 6
Maintenance Does Not Comply To Manufacturers Recommendations 6 6
Material Integrity Problem 5 5
Insufficient Information 5 5
Detachment Of Device Component 5 5
Crack 4 4
Leak/Splash 4 4
Mechanical Problem 3 3
Smoking 2 2
Microbial Contamination of Device 2 2
Component Falling 2 2
Fracture 2 2
Appropriate Term/Code Not Available 1 1
Physical Resistance/Sticking 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Blocked Connection 1 1
Inflation Problem 1 1
Detachment of Device or Device Component 1 1
Device Damaged by Another Device 1 1
Device Dislodged or Dislocated 1 1
Electrical Shorting 1 1
Flare or Flash 1 1
Device Contamination with Chemical or Other Material 1 1
Contamination 1 1
Charred 1 1
No Display/Image 1 1
Electrical /Electronic Property Problem 1 1
Fluid Leak 1 1
Component Missing 1 1
Device Issue 1 1
Arcing 1 1
Failure to Cut 1 1
Failure to Power Up 1 1
Difficult to Remove 1 1
Retraction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 22 22
Foreign Body In Patient 13 13
Bacterial Infection 10 10
No Clinical Signs, Symptoms or Conditions 8 8
No Known Impact Or Consequence To Patient 7 7
Patient Problem/Medical Problem 6 6
Device Embedded In Tissue or Plaque 5 5
Insufficient Information 3 3
Unspecified Infection 3 3
Urinary Tract Infection 3 3
No Patient Involvement 2 2
No Information 2 2
Unspecified Kidney or Urinary Problem 2 2
Abrasion 1 1
Scar Excision 1 1
Tissue Damage 1 1
Burn(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems II May-29-2020
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