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TPLC
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show TPLC since
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Device
cystourethroscope
Product Code
FBO
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
28
28
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
13
13
Microbial Contamination of Device
8
8
Material Integrity Problem
7
7
Material Fragmentation
7
7
Insufficient Information
6
6
Leak/Splash
4
4
Device Contamination with Chemical or Other Material
3
3
Fracture
3
3
Sparking
3
3
Mechanical Problem
3
3
Adverse Event Without Identified Device or Use Problem
3
3
No Apparent Adverse Event
2
2
Calcified
2
2
Optical Obstruction
2
2
Crack
2
2
Peeled/Delaminated
2
2
Contamination
2
2
Smoking
1
1
Appropriate Term/Code Not Available
1
1
Device Dislodged or Dislocated
1
1
Electrical /Electronic Property Problem
1
1
Fluid/Blood Leak
1
1
Misfocusing
1
1
Separation Problem
1
1
Physical Resistance/Sticking
1
1
No Display/Image
1
1
Material Puncture/Hole
1
1
Material Invagination
1
1
Difficult to Remove
1
1
Use of Device Problem
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
Inflation Problem
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
Foreign Body In Patient
13
13
Bacterial Infection
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
Unspecified Kidney or Urinary Problem
4
4
Urinary Tract Infection
4
4
Skin Inflammation/ Irritation
2
2
Post Operative Wound Infection
2
2
No Patient Involvement
2
2
Intra-Abdominal Hemorrhage
1
1
Scar Excision
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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