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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cystourethroscope
Product CodeFBO
Regulation Number 876.1500
Device Class 2

MDR Year MDR Reports MDR Events
2019 15 15
2020 20 20
2021 18 18
2022 33 33
2023 29 29
2024 26 26

Device Problems MDRs with this Device Problem Events in those MDRs
Break 29 29
Material Separation 17 17
Contamination /Decontamination Problem 17 17
Detachment of Device or Device Component 12 12
Microbial Contamination of Device 8 8
Material Fragmentation 7 7
Material Integrity Problem 7 7
Insufficient Information 6 6
Leak/Splash 4 4
Mechanical Problem 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Sparking 3 3
Fracture 3 3
Device Contamination with Chemical or Other Material 3 3
Optical Obstruction 2 2
No Apparent Adverse Event 2 2
Calcified 2 2
Contamination 2 2
Crack 2 2
Peeled/Delaminated 2 2
Failure to Power Up 1 1
Material Puncture/Hole 1 1
Difficult to Remove 1 1
Component Missing 1 1
Smoking 1 1
Material Perforation 1 1
No Display/Image 1 1
Electrical /Electronic Property Problem 1 1
Fluid/Blood Leak 1 1
Misfocusing 1 1
Inflation Problem 1 1
Material Invagination 1 1
Appropriate Term/Code Not Available 1 1
Physical Resistance/Sticking 1 1
Separation Problem 1 1
Blocked Connection 1 1
Device Damaged by Another Device 1 1
Device Dislodged or Dislocated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 45 45
Insufficient Information 24 24
Unspecified Infection 16 16
Bacterial Infection 13 13
Foreign Body In Patient 13 13
No Consequences Or Impact To Patient 12 12
Patient Problem/Medical Problem 6 6
No Known Impact Or Consequence To Patient 5 5
Device Embedded In Tissue or Plaque 5 5
Urinary Tract Infection 4 4
Unspecified Kidney or Urinary Problem 4 4
Skin Inflammation/ Irritation 2 2
Post Operative Wound Infection 2 2
No Patient Involvement 2 2
Scar Excision 1 1
Unspecified Heart Problem 1 1
Intra-Abdominal Hemorrhage 1 1
Unspecified Hepatic or Biliary Problem 1 1
Bruise/Contusion 1 1
Burn(s) 1 1
Fever 1 1
Hemorrhage/Bleeding 1 1
Pain 1 1
Pneumonia 1 1
Tissue Damage 1 1
Urinary Retention 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems II May-29-2020
2 Karl Storz Endoscopy II May-12-2022
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