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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
2016
125
125
2017
324
324
2018
378
378
2019
472
472
2020
433
433
2021
614
614
2022
545
545
2023
810
810
2024
157
157
Device Problems
MDRs with this Device Problem
Events in those MDRs
Failure to Cut
1436
1436
Power Problem
416
416
Unstable
330
330
Intermittent Loss of Power
252
252
Patient Device Interaction Problem
243
243
Gas/Air Leak
235
235
Device Operates Differently Than Expected
205
205
Appropriate Term/Code Not Available
174
174
Material Frayed
160
160
Calibration Problem
159
159
Mechanical Problem
120
120
Loss of Power
105
105
Component Missing
93
93
Noise, Audible
93
93
Failure to Power Up
90
90
Output Problem
83
83
Incorrect, Inadequate or Imprecise Result or Readings
81
81
Material Deformation
77
77
Naturally Worn
62
62
Incorrect Measurement
62
62
Break
60
60
Corroded
58
58
Insufficient Information
56
56
Fitting Problem
51
51
Loose or Intermittent Connection
50
50
Physical Resistance/Sticking
46
46
Electrical /Electronic Property Problem
43
43
Adverse Event Without Identified Device or Use Problem
37
37
Output below Specifications
31
31
Material Integrity Problem
25
25
Air Leak
25
25
Positioning Problem
24
24
Vibration
23
23
Structural Problem
22
22
Material Twisted/Bent
21
21
Mechanics Altered
18
18
Material Split, Cut or Torn
18
18
Device Stops Intermittently
16
16
Detachment of Device or Device Component
14
14
Electrical Power Problem
14
14
Dull, Blunt
13
13
Device Inoperable
13
13
Fluid/Blood Leak
13
13
Improper or Incorrect Procedure or Method
12
12
Failure to Calibrate
12
12
Device Contaminated During Manufacture or Shipping
11
11
Pressure Problem
11
11
Overheating of Device
11
11
Misassembly by Users
10
10
Activation Problem
10
10
Use of Device Problem
9
9
Misassembled
9
9
Mechanical Jam
8
8
Unexpected Shutdown
8
8
Connection Problem
7
7
Defective Device
7
7
Degraded
7
7
Leak/Splash
6
6
Device Damaged Prior to Use
6
6
Malposition of Device
6
6
Failure to Obtain Sample
6
6
Failure to Shut Off
6
6
Improper Device Output
6
6
Electrical Shorting
5
5
Temperature Problem
5
5
Complete Loss of Power
5
5
Excessive Heating
4
4
Device Operational Issue
4
4
Defective Component
4
4
Difficult to Remove
4
4
Sticking
4
4
Output above Specifications
4
4
Material Puncture/Hole
4
4
Delivered as Unsterile Product
4
4
Device Emits Odor
3
3
Partial Blockage
3
3
Flaked
3
3
Imprecision
3
3
Positioning Failure
3
3
Unintended Power Up
3
3
Circuit Failure
3
3
Energy Output Problem
3
3
Device Markings/Labelling Problem
3
3
Improper Flow or Infusion
3
3
Device Contamination with Chemical or Other Material
3
3
Therapeutic or Diagnostic Output Failure
3
3
Packaging Problem
2
2
Manufacturing, Packaging or Shipping Problem
2
2
Difficult to Open or Close
2
2
Device Handling Problem
2
2
Expulsion
2
2
Failure to Disconnect
2
2
Sparking
2
2
Off-Label Use
2
2
Product Quality Problem
2
2
Inadequacy of Device Shape and/or Size
2
2
Power Conditioning Problem
2
2
Unexpected Therapeutic Results
2
2
Out-Of-Box Failure
2
2
Device Issue
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1799
1799
No Consequences Or Impact To Patient
504
504
No Known Impact Or Consequence To Patient
454
454
No Patient Involvement
407
407
Abrasion
334
334
Laceration(s)
256
256
No Code Available
101
101
Insufficient Information
67
67
Injury
52
52
Tissue Damage
44
44
Unspecified Tissue Injury
42
42
No Information
35
35
Scar Tissue
17
17
Suture Abrasion
16
16
Scarring
14
14
Skin Tears
11
11
Localized Skin Lesion
9
9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
7
7
Physical Asymmetry
4
4
Muscle/Tendon Damage
4
4
Impaired Healing
3
3
Hematoma
3
3
Burn(s)
3
3
Failure of Implant
2
2
Unspecified Infection
2
2
Pain
2
2
Wound Dehiscence
2
2
Patient Problem/Medical Problem
2
2
Wrinkling
1
1
Partial thickness (Second Degree) Burn
1
1
Full thickness (Third Degree) Burn
1
1
Sedation
1
1
Tissue Breakdown
1
1
Superficial (First Degree) Burn
1
1
Fluid Discharge
1
1
Crushing Injury
1
1
Adhesion(s)
1
1
Skin Irritation
1
1
Sprain
1
1
Perforation of Vessels
1
1
Complaint, Ill-Defined
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Exsurco Medical
II
Jun-26-2018
2
Integra LifeSciences Corp.
II
Sep-12-2020
3
Zimmer Surgical Inc
II
Oct-06-2023
4
Zimmer Surgical Inc
II
Aug-03-2018
5
Zimmer Surgical Inc
II
Nov-05-2016
6
Zimmer Surgical Inc
II
Aug-04-2016
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