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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


Premarket Reviews
ManufacturerDecision
KARL STORZ SE & CO. KG
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 20 20
2021 18 18
2022 33 33
2023 29 29
2024 30 30

Device Problems MDRs with this Device Problem Events in those MDRs
Break 26 26
Contamination /Decontamination Problem 17 17
Detachment of Device or Device Component 13 13
Material Separation 12 12
Microbial Contamination of Device 8 8
Material Integrity Problem 7 7
Insufficient Information 6 6
Material Fragmentation 6 6
Fracture 5 5
Leak/Splash 4 4
Mechanical Problem 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Device Contamination with Chemical or Other Material 3 3
Peeled/Delaminated 2 2
Use of Device Problem 2 2
No Apparent Adverse Event 2 2
Calcified 2 2
Optical Obstruction 2 2
Sparking 1 1
Separation Problem 1 1
Physical Resistance/Sticking 1 1
Crack 1 1
Material Invagination 1 1
Material Puncture/Hole 1 1
Smoking 1 1
Contamination 1 1
Difficult to Remove 1 1
Failure to Power Up 1 1
Component Missing 1 1
Material Perforation 1 1
Blocked Connection 1 1
Device Damaged by Another Device 1 1
Material Deformation 1 1
Device Dislodged or Dislocated 1 1
Appropriate Term/Code Not Available 1 1
Electrical /Electronic Property Problem 1 1
Misfocusing 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 46 46
Insufficient Information 26 26
Unspecified Infection 16 16
Bacterial Infection 13 13
Foreign Body In Patient 10 10
No Consequences Or Impact To Patient 7 7
Unspecified Kidney or Urinary Problem 4 4
Device Embedded In Tissue or Plaque 4 4
Urinary Tract Infection 4 4
Patient Problem/Medical Problem 3 3
Skin Inflammation/ Irritation 2 2
No Known Impact Or Consequence To Patient 2 2
Post Operative Wound Infection 2 2
No Patient Involvement 2 2
Unintended Radiation Exposure 2 2
Intra-Abdominal Hemorrhage 1 1
Burn(s) 1 1
Fever 1 1
Urinary Retention 1 1
Pain 1 1
Unspecified Hepatic or Biliary Problem 1 1
Pneumonia 1 1
Tissue Damage 1 1
Unspecified Heart Problem 1 1
Hemorrhage/Bleeding 1 1
Bruise/Contusion 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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