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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device forceps, biopsy, non-electric
Product CodeFCL
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 Boston Scientific Corporation II Jun-04-2010
2 Cook Inc. II Aug-22-2016
3 Richard Wolf GmbH II Apr-24-2023
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