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TPLC
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Device
cystourethroscope
Product Code
FBO
Regulation Number
876.1500
Device Class
2
Premarket Reviews
Manufacturer
Decision
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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