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TPLC
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show TPLC since
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Device
laryngoscope, endoscope
Regulation Description
Endoscope and accessories.
Product Code
GCI
Regulation Number
876.1500
Device Class
2
MDR Year
MDR Reports
MDR Events
2020
129
129
2021
96
96
2022
102
102
2023
101
101
2024
119
119
2025
15
15
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Split, Cut or Torn
412
412
Detachment of Device or Device Component
108
108
Material Separation
51
51
Break
45
45
Adverse Event Without Identified Device or Use Problem
13
13
Difficult to Remove
4
4
Display or Visual Feedback Problem
4
4
Insufficient Information
4
4
Mechanics Altered
3
3
Defective Device
3
3
Entrapment of Device
3
3
Difficult to Insert
3
3
No Apparent Adverse Event
2
2
Device Difficult to Maintain
2
2
Tear, Rip or Hole in Device Packaging
1
1
Activation Problem
1
1
Material Protrusion/Extrusion
1
1
Material Rupture
1
1
Optical Problem
1
1
Difficult to Open or Close
1
1
Patient Device Interaction Problem
1
1
Device Dislodged or Dislocated
1
1
Physical Resistance/Sticking
1
1
Failure to Align
1
1
Unexpected Therapeutic Results
1
1
No Display/Image
1
1
Smoking
1
1
Retraction Problem
1
1
Mechanical Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
344
344
No Consequences Or Impact To Patient
80
80
Insufficient Information
78
78
No Information
26
26
Unspecified Tissue Injury
20
20
Foreign Body In Patient
17
17
No Code Available
12
12
Laceration(s)
7
7
Unintended Radiation Exposure
5
5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
No Patient Involvement
3
3
Vascular Dissection
3
3
Death
2
2
Unspecified Infection
2
2
Tissue Breakdown
2
2
Device Embedded In Tissue or Plaque
2
2
Exposure to Body Fluids
1
1
Purulent Discharge
1
1
Exsanguination
1
1
Hemorrhage/Bleeding
1
1
Injury
1
1
Post Traumatic Wound Infection
1
1
Tissue Damage
1
1
Rupture
1
1
No Known Impact Or Consequence To Patient
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Covidien Llc
II
Jun-03-2020
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