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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device forceps, general & plastic surgery
Product CodeGEN
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2019 18 18
2020 6 6
2021 20 20
2022 18 18
2023 25 25
2024 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Break 41 41
Difficult to Open or Close 8 8
Material Fragmentation 6 6
Detachment of Device or Device Component 6 6
Mechanical Problem 4 4
Material Integrity Problem 4 4
Material Twisted/Bent 3 3
Material Separation 3 3
Fracture 3 3
Improper or Incorrect Procedure or Method 3 3
Device-Device Incompatibility 2 2
Entrapment of Device 2 2
Crack 2 2
Device Fell 2 2
Defective Device 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Material Deformation 2 2
Disconnection 1 1
Leak/Splash 1 1
Output Problem 1 1
Insufficient Information 1 1
Inadequate Instructions for Healthcare Professional 1 1
Contamination /Decontamination Problem 1 1
Degraded 1 1
Component Missing 1 1
Failure to Cut 1 1
Difficult or Delayed Separation 1 1
Product Quality Problem 1 1
No Apparent Adverse Event 1 1
Device Dislodged or Dislocated 1 1
Appropriate Term/Code Not Available 1 1
Device Reprocessing Problem 1 1
Deformation Due to Compressive Stress 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 49 49
Foreign Body In Patient 9 9
Insufficient Information 9 9
No Consequences Or Impact To Patient 9 9
No Known Impact Or Consequence To Patient 8 8
Device Embedded In Tissue or Plaque 4 4
Laceration(s) 3 3
Hemorrhage/Bleeding 3 3
Tooth Fracture 2 2
No Patient Involvement 2 2
Low Blood Pressure/ Hypotension 2 2
Unspecified Infection 1 1
No Code Available 1 1
No Information 1 1
Pericardial Effusion 1 1
Injury 1 1
Respiratory Distress Syndrome of Newborns 1 1
Low Oxygen Saturation 1 1
Unintended Radiation Exposure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield II Mar-29-2024
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