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TPLC
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show TPLC since
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Device
dermatome
Product Code
GFD
Regulation Number
878.4820
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
472
472
2020
433
433
2021
614
614
2022
545
545
2023
810
810
2024
204
204
Device Problems
MDRs with this Device Problem
Events in those MDRs
Failure to Cut
1066
1066
Power Problem
381
381
Unstable
338
338
Patient Device Interaction Problem
248
248
Intermittent Loss of Power
243
243
Gas/Air Leak
212
212
Appropriate Term/Code Not Available
169
169
Material Frayed
155
155
Calibration Problem
132
132
Mechanical Problem
109
109
Component Missing
85
85
Noise, Audible
82
82
Incorrect, Inadequate or Imprecise Result or Readings
81
81
Material Deformation
76
76
Failure to Power Up
75
75
Loss of Power
69
69
Output Problem
63
63
Naturally Worn
61
61
Corroded
57
57
Break
51
51
Insufficient Information
51
51
Loose or Intermittent Connection
48
48
Physical Resistance/Sticking
48
48
Fitting Problem
45
45
Electrical /Electronic Property Problem
42
42
Adverse Event Without Identified Device or Use Problem
32
32
Incorrect Measurement
31
31
Output below Specifications
30
30
Positioning Problem
24
24
Material Integrity Problem
23
23
Structural Problem
22
22
Material Twisted/Bent
21
21
Material Split, Cut or Torn
20
20
Vibration
19
19
Electrical Power Problem
14
14
Detachment of Device or Device Component
14
14
Dull, Blunt
13
13
Overheating of Device
11
11
Pressure Problem
10
10
Activation Problem
10
10
Fluid/Blood Leak
8
8
Unexpected Shutdown
7
7
Failure to Calibrate
7
7
Degraded
7
7
Misassembled
6
6
Connection Problem
6
6
Complete Loss of Power
6
6
Failure to Shut Off
5
5
Defective Device
5
5
Mechanical Jam
5
5
Electrical Shorting
5
5
Use of Device Problem
5
5
Improper or Incorrect Procedure or Method
5
5
Defective Component
4
4
Material Puncture/Hole
4
4
Excessive Heating
4
4
Temperature Problem
4
4
Improper Flow or Infusion
3
3
Device Damaged Prior to Use
3
3
Leak/Splash
3
3
Positioning Failure
3
3
Therapeutic or Diagnostic Output Failure
3
3
Output above Specifications
3
3
Circuit Failure
3
3
Difficult to Remove
3
3
Unexpected Therapeutic Results
2
2
Delivered as Unsterile Product
2
2
Unintended Power Up
2
2
Difficult to Open or Close
2
2
Off-Label Use
2
2
Misassembly by Users
2
2
Expulsion
2
2
Failure to Disconnect
2
2
Malposition of Device
2
2
Imprecision
2
2
Mechanics Altered
2
2
Gel Leak
2
2
Device Slipped
1
1
Packaging Problem
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Flaked
1
1
Audible Prompt/Feedback Problem
1
1
Difficult to Insert
1
1
Thermal Decomposition of Device
1
1
Restricted Flow rate
1
1
Device Markings/Labelling Problem
1
1
Unclear Information
1
1
Device Handling Problem
1
1
Use of Incorrect Control/Treatment Settings
1
1
Material Too Rigid or Stiff
1
1
Device Emits Odor
1
1
Failure to Clean Adequately
1
1
Unintended Movement
1
1
Inadequacy of Device Shape and/or Size
1
1
Obstruction of Flow
1
1
Smoking
1
1
Activation, Positioning or Separation Problem
1
1
Failure to Deliver
1
1
Explosion
1
1
Unintended System Motion
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1842
1842
No Patient Involvement
332
332
No Consequences Or Impact To Patient
263
263
Laceration(s)
223
223
No Known Impact Or Consequence To Patient
219
219
Abrasion
175
175
Insufficient Information
67
67
Unspecified Tissue Injury
42
42
No Code Available
42
42
Scar Tissue
15
15
Injury
15
15
Localized Skin Lesion
9
9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
7
7
Skin Tears
5
5
Physical Asymmetry
4
4
Muscle/Tendon Damage
4
4
No Information
3
3
Suture Abrasion
3
3
Burn(s)
3
3
Scarring
2
2
Tissue Damage
2
2
Failure of Implant
2
2
Impaired Healing
2
2
Patient Problem/Medical Problem
2
2
Partial thickness (Second Degree) Burn
1
1
Full thickness (Third Degree) Burn
1
1
Sedation
1
1
Wrinkling
1
1
Tissue Breakdown
1
1
Superficial (First Degree) Burn
1
1
Pain
1
1
Crushing Injury
1
1
Hematoma
1
1
Adhesion(s)
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Integra LifeSciences Corp.
II
Sep-12-2020
2
Zimmer Surgical Inc
II
Oct-06-2023
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