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TPLC
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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
2014
86
86
2015
51
51
2016
64
64
2017
275
275
2018
69
69
2019
69
69
2020
53
53
2021
30
30
2022
70
70
2023
68
68
2024
25
25
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Operates Differently Than Expected
259
259
Adverse Event Without Identified Device or Use Problem
161
161
Difficult to Open or Close
96
96
Break
63
63
Dull, Blunt
46
46
Device Contamination with Chemical or Other Material
45
45
Material Separation
35
35
Failure to Cut
24
24
Failure to Align
22
22
Mechanical Problem
16
16
Material Twisted/Bent
16
16
Detachment Of Device Component
13
13
Use of Device Problem
13
13
Device Handling Problem
12
12
Insufficient Information
11
11
Physical Resistance/Sticking
10
10
Material Protrusion/Extrusion
10
10
Detachment of Device or Device Component
10
10
Difficult to Remove
10
10
Human-Device Interface Problem
8
8
Device Contaminated During Manufacture or Shipping
8
8
Solder Joint Fracture
7
7
Material Fragmentation
7
7
Bent
6
6
Mechanical Jam
6
6
Appropriate Term/Code Not Available
6
6
Delivered as Unsterile Product
5
5
Entrapment of Device
5
5
Material Integrity Problem
4
4
Device Or Device Fragments Location Unknown
3
3
Component Falling
3
3
Retraction Problem
3
3
Improper or Incorrect Procedure or Method
3
3
Device Damaged Prior to Use
3
3
Shipping Damage or Problem
3
3
Component Missing
2
2
Fracture
2
2
Unsealed Device Packaging
2
2
Defective Device
2
2
Material Deformation
2
2
Mechanics Altered
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Activation Failure
1
1
Noise, Audible
1
1
Material Split, Cut or Torn
1
1
Packaging Problem
1
1
Physical Property Issue
1
1
Protective Measures Problem
1
1
Scratched Material
1
1
Therapeutic or Diagnostic Output Failure
1
1
Torn Material
1
1
Cut In Material
1
1
Structural Problem
1
1
Sparking
1
1
Patient-Device Incompatibility
1
1
Deformation Due to Compressive Stress
1
1
Activation, Positioning or Separation Problem
1
1
Device Misassembled During Manufacturing /Shipping
1
1
Device Dislodged or Dislocated
1
1
Device Damaged by Another Device
1
1
Device Packaging Compromised
1
1
Device-Device Incompatibility
1
1
Difficult to Advance
1
1
Loss of Power
1
1
Premature Activation
1
1
Off-Label Use
1
1
Product Quality Problem
1
1
Difficult to Insert
1
1
Leak/Splash
1
1
Misassembled
1
1
Nonstandard Device
1
1
Device Reprocessing Problem
1
1
Contamination
1
1
Degraded
1
1
Disconnection
1
1
Energy Output To Patient Tissue Incorrect
1
1
Sticking
1
1
Stretched
1
1
Device Inoperable
1
1
Material Too Rigid or Stiff
1
1
Failure to Advance
1
1
Misfire
1
1
Failure to Obtain Sample
1
1
Physical Resistance
1
1
Wrong Label
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
376
376
No Clinical Signs, Symptoms or Conditions
118
118
No Known Impact Or Consequence To Patient
84
84
Hemorrhage/Bleeding
65
65
Tissue Damage
57
57
Blood Loss
41
41
Hematoma
32
32
Hemostasis
21
21
No Patient Involvement
20
20
Foreign Body In Patient
18
18
Pancreatitis
14
14
Insufficient Information
14
14
No Information
14
14
Pneumothorax
13
13
Unspecified Tissue Injury
12
12
Perforation
11
11
Injury
10
10
Unspecified Hepatic or Biliary Problem
9
9
No Code Available
8
8
Hematuria
8
8
Fever
8
8
Inflammation
7
7
Laceration(s)
6
6
Abdominal Pain
5
5
Unspecified Infection
4
4
Excessive Tear Production
4
4
Vomiting
4
4
Urinary Tract Infection
3
3
Renal Failure
3
3
Chest Pain
3
3
Dysuria
3
3
Device Embedded In Tissue or Plaque
3
3
Unspecified Mental, Emotional or Behavioural Problem
2
2
Perforation of Esophagus
2
2
Cramp(s) /Muscle Spasm(s)
2
2
Liver Failure
2
2
Death
2
2
Fistula
2
2
Pneumonia
2
2
Urinary Retention
2
2
Megophthalmos
1
1
Discomfort
1
1
Sepsis
1
1
Septic Shock
1
1
Tachycardia
1
1
Micturition Urgency
1
1
Hypovolemic Shock
1
1
Liver Laceration(s)
1
1
Pain
1
1
Dyspnea
1
1
Pulmonary Embolism
1
1
Syncope
1
1
Air Embolism
1
1
Angina
1
1
Atrial Flutter
1
1
Bruise/Contusion
1
1
Urinary Incontinence
1
1
Swelling/ Edema
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Loss of consciousness
1
1
Obstruction/Occlusion
1
1
Post Operative Wound Infection
1
1
Burn, Thermal
1
1
Laceration(s) of Esophagus
1
1
Alteration In Body Temperature
1
1
Heart Failure/Congestive Heart Failure
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Cook Inc.
II
Aug-22-2016
2
Richard Wolf GmbH
II
Apr-24-2023
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