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TPLC
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Device
apparatus, exhaust, surgical
Regulation Description
Air-handling apparatus for a surgical operating room.
Product Code
FYD
Regulation Number
878.5070
Device Class
2
Premarket Reviews
Manufacturer
Decision
CONMED CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MEDLINE INDUSTRIES, INC.
SUBSTANTIALLY EQUIVALENT
1
MEGADYNE MEDICAL PRODUCTS, INC.
SUBSTANTIALLY EQUIVALENT
1
NORTHGATE TECHNOLOGIES INC.
SUBSTANTIALLY EQUIVALENT
1
SURNIC CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
11
11
2021
20
20
2022
46
46
2023
19
19
2024
11
11
2025
9
9
Device Problems
MDRs with this Device Problem
Events in those MDRs
Difficult or Delayed Activation
61
61
Adverse Event Without Identified Device or Use Problem
11
11
Noise, Audible
9
9
Ventilation Problem in Device Environment
9
9
Electrical Shorting
6
6
Arcing of Electrodes
5
5
Self-Activation or Keying
5
5
Appropriate Term/Code Not Available
5
5
Intermittent Energy Output
4
4
Melted
3
3
Fire
3
3
Smoking
3
3
Flaked
2
2
Failure to Calibrate
2
2
Activation Failure
2
2
Delivered as Unsterile Product
2
2
Structural Problem
2
2
Decrease in Suction
2
2
Therapeutic or Diagnostic Output Failure
2
2
Defective Device
2
2
Break
2
2
Material Integrity Problem
1
1
Defective Component
1
1
Insufficient Information
1
1
Unintended Electrical Shock
1
1
Electrical Power Problem
1
1
Device Emits Odor
1
1
Material Separation
1
1
Detachment of Device or Device Component
1
1
Unintended Power Up
1
1
Physical Resistance/Sticking
1
1
Computer Software Problem
1
1
Output Problem
1
1
Protective Measures Problem
1
1
Communication or Transmission Problem
1
1
Intermittent Continuity
1
1
Suction Problem
1
1
Human-Device Interface Problem
1
1
Overheating of Device
1
1
Material Split, Cut or Torn
1
1
Sparking
1
1
Device Displays Incorrect Message
1
1
Arcing at Paddles
1
1
Fluid/Blood Leak
1
1
Premature Activation
1
1
Fumes or Vapors
1
1
Temperature Problem
1
1
Circuit Failure
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
85
85
Insufficient Information
8
8
Partial thickness (Second Degree) Burn
5
5
No Known Impact Or Consequence To Patient
4
4
Burn(s)
2
2
Hemorrhage/Bleeding
2
2
No Consequences Or Impact To Patient
2
2
Superficial (First Degree) Burn
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
No Information
1
1
Blister
1
1
Rash
1
1
Burning Sensation
1
1
Foreign Body In Patient
1
1
No Patient Involvement
1
1
Scar Tissue
1
1
Unspecified Tissue Injury
1
1
Caustic/Chemical Burns
1
1
Full thickness (Third Degree) Burn
1
1
Skin Burning Sensation
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Mckesson Medical-Surgical Inc. Corporate Office
III
Sep-26-2022
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