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TPLC
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show TPLC since
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2024
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Device
forceps, biopsy, non-electric
Product Code
FCL
Regulation Number
876.1075
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
69
69
2020
53
53
2021
30
30
2022
70
70
2023
68
68
2024
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Difficult to Open or Close
82
82
Adverse Event Without Identified Device or Use Problem
58
58
Break
24
24
Failure to Cut
22
22
Dull, Blunt
18
18
Material Twisted/Bent
16
16
Device Contamination with Chemical or Other Material
15
15
Mechanical Problem
14
14
Use of Device Problem
10
10
Physical Resistance/Sticking
10
10
Difficult to Remove
8
8
Device Contaminated During Manufacture or Shipping
7
7
Insufficient Information
7
7
Appropriate Term/Code Not Available
6
6
Mechanical Jam
6
6
Human-Device Interface Problem
6
6
Detachment of Device or Device Component
5
5
Delivered as Unsterile Product
5
5
Entrapment of Device
5
5
Material Protrusion/Extrusion
5
5
Shipping Damage or Problem
3
3
Device Damaged Prior to Use
3
3
Unsealed Device Packaging
2
2
Retraction Problem
2
2
Material Fragmentation
2
2
Material Deformation
2
2
Material Integrity Problem
2
2
Mechanics Altered
1
1
Activation Failure
1
1
Material Split, Cut or Torn
1
1
Wrong Label
1
1
Therapeutic or Diagnostic Output Failure
1
1
Difficult to Insert
1
1
Misassembled
1
1
Device Reprocessing Problem
1
1
Contamination
1
1
Degraded
1
1
Material Separation
1
1
Product Quality Problem
1
1
Stretched
1
1
Improper or Incorrect Procedure or Method
1
1
Component Missing
1
1
Structural Problem
1
1
Failure to Advance
1
1
Defective Device
1
1
Deformation Due to Compressive Stress
1
1
Activation, Positioning or Separation Problem
1
1
Device Damaged by Another Device
1
1
Device Dislodged or Dislocated
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
118
118
No Known Impact Or Consequence To Patient
39
39
Hemorrhage/Bleeding
35
35
No Consequences Or Impact To Patient
29
29
Pancreatitis
14
14
Insufficient Information
13
13
Unspecified Tissue Injury
11
11
Tissue Damage
10
10
Unspecified Hepatic or Biliary Problem
9
9
Foreign Body In Patient
8
8
Hematoma
8
8
Blood Loss
7
7
No Patient Involvement
5
5
Excessive Tear Production
4
4
Perforation
4
4
Pneumothorax
3
3
No Code Available
3
3
Inflammation
3
3
Death
2
2
Vomiting
2
2
Fistula
2
2
Device Embedded In Tissue or Plaque
2
2
Pneumonia
2
2
No Information
2
2
Liver Failure
2
2
Bruise/Contusion
1
1
Dyspnea
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Fever
1
1
Air Embolism
1
1
Abdominal Pain
1
1
Septic Shock
1
1
Sepsis
1
1
Laceration(s)
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Richard Wolf GmbH
II
Apr-24-2023
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