Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
Back to Search Results
Device
cannula, surgical, general & plastic surgery
Regulation Description
Manual surgical instrument for general use.
Product Code
GEA
Regulation Number
878.4800
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
158
158
2021
149
149
2022
83
83
2023
74
76
2024
99
99
2025
29
29
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
120
120
Device Markings/Labelling Problem
114
114
Device-Device Incompatibility
100
100
Delivered as Unsterile Product
52
52
Adverse Event Without Identified Device or Use Problem
37
37
Material Deformation
36
36
Crack
29
29
Material Twisted/Bent
22
22
Detachment of Device or Device Component
16
16
Fluid/Blood Leak
14
14
Material Separation
14
14
Mechanical Jam
12
12
Entrapment of Device
11
11
Material Integrity Problem
8
8
Contamination /Decontamination Problem
8
8
Packaging Problem
8
8
Device Contaminated During Manufacture or Shipping
4
4
Material Fragmentation
4
4
Contamination
3
3
Fracture
3
3
Device Slipped
2
2
Improper or Incorrect Procedure or Method
2
2
Defective Component
2
2
Use of Device Problem
2
2
Device Contamination with Chemical or Other Material
2
2
Product Quality Problem
2
2
Dull, Blunt
1
1
Difficult to Open or Close
1
1
Complete Loss of Power
1
1
Connection Problem
1
1
Nonstandard Device
1
1
Appropriate Term/Code Not Available
1
1
Protective Measures Problem
1
1
Missing Information
1
1
Component Misassembled
1
1
No Apparent Adverse Event
1
1
Misassembly by Users
1
1
Solder Joint Fracture
1
1
Material Rupture
1
1
Misassembled
1
1
Structural Problem
1
1
Positioning Failure
1
1
Device Misassembled During Manufacturing /Shipping
1
1
Defective Device
1
3
Material Puncture/Hole
1
1
Material Erosion
1
1
Device Damaged Prior to Use
1
1
Mechanical Problem
1
1
Burst Container or Vessel
1
1
Component or Accessory Incompatibility
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
385
387
No Consequences Or Impact To Patient
133
133
Insufficient Information
24
24
Foreign Body In Patient
20
20
Abscess
7
7
Pain
7
7
Unspecified Infection
5
5
Hemorrhage/Bleeding
5
5
Device Embedded In Tissue or Plaque
4
4
No Patient Involvement
4
4
Hernia
4
4
Obstruction/Occlusion
4
4
Needle Stick/Puncture
4
4
Fistula
3
3
Wound Dehiscence
3
3
Failure to Anastomose
3
3
No Code Available
3
3
Inflammation
3
3
Pleural Effusion
3
3
Cardiac Tamponade
3
3
Post Operative Wound Infection
3
3
No Known Impact Or Consequence To Patient
3
3
Fever
2
2
Peritonitis
2
2
Blood Loss
2
2
Not Applicable
2
2
Abdominal Pain
2
2
Seroma
1
1
Incontinence
1
1
Vomiting
1
1
Perforation
1
1
Discomfort
1
1
Hematoma
1
1
Adhesion(s)
1
1
Sepsis
1
1
Nausea
1
1
Unspecified Tissue Injury
1
1
Swelling/ Edema
1
1
Pneumothorax
1
1
Ectopic Pregnancy
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Unintended Radiation Exposure
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
CLINICAL LASERTHERMIA SYSTEMS AB
II
Jun-04-2021
2
Cardinal Health 200, LLC
II
Mar-09-2020
3
Genicon, Inc.
II
Jun-05-2020
4
Sklar Instruments
II
Jan-16-2025
5
TeDan Surgical Innovations LLC
II
May-01-2020
-
-