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TPLC
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Device
dermatome
Regulation Description
Surgical instrument motors and accessories/attachments.
Product Code
GFD
Regulation Number
878.4820
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
433
433
2021
614
614
2022
545
545
2023
810
810
2024
797
797
2025
318
318
Device Problems
MDRs with this Device Problem
Events in those MDRs
Failure to Cut
1201
1201
Unstable
434
434
Patient Device Interaction Problem
377
377
Power Problem
368
368
Appropriate Term/Code Not Available
292
292
Intermittent Loss of Power
242
242
Gas/Air Leak
227
227
Calibration Problem
157
157
Material Frayed
142
142
Noise, Audible
130
130
Material Deformation
112
112
Mechanical Problem
110
110
Failure to Power Up
109
109
Component Missing
100
100
Naturally Worn
99
99
Incorrect, Inadequate or Imprecise Result or Readings
78
78
Corroded
75
75
Loose or Intermittent Connection
73
73
Physical Resistance/Sticking
70
70
Insufficient Information
68
68
Break
64
64
Fitting Problem
58
58
Output Problem
52
52
Output below Specifications
52
52
Electrical /Electronic Property Problem
42
42
Material Integrity Problem
32
32
Adverse Event Without Identified Device or Use Problem
30
30
Incorrect Measurement
28
28
Positioning Problem
25
25
Detachment of Device or Device Component
24
24
Material Twisted/Bent
22
22
Structural Problem
22
22
Activation Problem
21
21
Loss of Power
19
19
Vibration
19
19
Pressure Problem
18
18
Unexpected Shutdown
18
18
Dull, Blunt
15
15
Material Split, Cut or Torn
15
15
Failure to Disconnect
14
14
Overheating of Device
13
13
Connection Problem
12
12
Key or Button Unresponsive/not Working
10
10
Complete Loss of Power
9
9
Electrical Power Problem
9
9
Fluid/Blood Leak
7
7
Mechanical Jam
7
7
Degraded
7
7
Use of Device Problem
7
7
Misassembled
6
6
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
2558
2558
Laceration(s)
310
310
No Consequences Or Impact To Patient
174
174
No Patient Involvement
170
170
Insufficient Information
165
165
Abrasion
131
131
No Known Impact Or Consequence To Patient
90
90
Unspecified Tissue Injury
62
62
Skin Tears
54
54
Scar Tissue
15
15
Injury
10
10
Impaired Healing
9
9
Localized Skin Lesion
9
9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
7
7
No Code Available
6
6
Physical Asymmetry
6
6
Muscle/Tendon Damage
4
4
Patient Problem/Medical Problem
2
2
Failure of Implant
2
2
No Information
2
2
Burn(s)
2
2
Superficial (First Degree) Burn
1
1
Adhesion(s)
1
1
Crushing Injury
1
1
Scarring
1
1
Suture Abrasion
1
1
Hair Loss
1
1
Partial Hearing Loss
1
1
Wrinkling
1
1
Tissue Damage
1
1
Partial thickness (Second Degree) Burn
1
1
Headache
1
1
Tissue Breakdown
1
1
Full thickness (Third Degree) Burn
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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