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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
375
375
Device Problems
MDRs with this Device Problem
Events in those MDRs
Failure to Cut
1219
1219
Unstable
434
434
Patient Device Interaction Problem
377
377
Power Problem
369
369
Appropriate Term/Code Not Available
298
298
Intermittent Loss of Power
242
242
Gas/Air Leak
230
230
Calibration Problem
160
160
Material Frayed
143
143
Noise, Audible
131
131
Material Deformation
113
113
Mechanical Problem
113
113
Failure to Power Up
111
111
Naturally Worn
102
102
Component Missing
101
101
Corroded
79
79
Incorrect, Inadequate or Imprecise Result or Readings
78
78
Loose or Intermittent Connection
73
73
Physical Resistance/Sticking
71
71
Insufficient Information
68
68
Break
65
65
Output below Specifications
60
60
Fitting Problem
60
60
Output Problem
52
52
Electrical /Electronic Property Problem
42
42
Material Integrity Problem
33
33
Incorrect Measurement
30
30
Adverse Event Without Identified Device or Use Problem
30
30
Positioning Problem
25
25
Detachment of Device or Device Component
24
24
Material Twisted/Bent
24
24
Activation Problem
22
22
Structural Problem
22
22
Unexpected Shutdown
20
20
Vibration
19
19
Loss of Power
19
19
Pressure Problem
18
18
Material Split, Cut or Torn
15
15
Dull, Blunt
15
15
Overheating of Device
15
15
Failure to Disconnect
14
14
Connection Problem
12
12
Key or Button Unresponsive/not Working
10
10
Complete Loss of Power
10
10
Electrical Power Problem
9
9
Mechanical Jam
7
7
Degraded
7
7
Use of Device Problem
7
7
Fluid/Blood Leak
7
7
Misassembled
6
6
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
2597
2597
Laceration(s)
314
314
Insufficient Information
191
191
No Consequences Or Impact To Patient
174
174
No Patient Involvement
170
170
Abrasion
131
131
No Known Impact Or Consequence To Patient
90
90
Unspecified Tissue Injury
63
63
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
Scarring
1
1
Suture Abrasion
1
1
Crushing Injury
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
Full thickness (Third Degree) Burn
1
1
Tissue Breakdown
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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