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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
Regulation Description Manual surgical instrument for general use.
Product CodeGEN
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2021 20 20
2022 18 18
2023 25 25
2024 20 20
2025 30 30
2026 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Break 48 48
Material Fragmentation 10 10
Tear, Rip or Hole in Device Packaging 8 8
Difficult to Open or Close 8 8
Detachment of Device or Device Component 7 7
Mechanical Problem 4 4
Fracture 4 4
Material Integrity Problem 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Device-Device Incompatibility 2 2
Entrapment of Device 2 2
Crack 2 2
Defective Device 2 2
Material Twisted/Bent 2 2
Packaging Problem 2 2
Product Quality Problem 2 2
Material Separation 2 2
Improper or Incorrect Procedure or Method 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
Component Missing 1 1
Failure to Cut 1 1
Material Deformation 1 1
Difficult or Delayed Separation 1 1
No Apparent Adverse Event 1 1
Device Dislodged or Dislocated 1 1
Protective Measures Problem 1 1
Device Reprocessing Problem 1 1
Connection 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 80 80
Insufficient Information 14 14
Foreign Body In Patient 11 11
Hemorrhage/Bleeding 6 6
Laceration(s) 3 3
Low Blood Pressure/ Hypotension 3 3
Tooth Fracture 2 2
Pericardial Effusion 2 2
Post Operative Wound Infection 2 2
Perforation of Vessels 2 2
Device Embedded In Tissue or Plaque 2 2
Unspecified Infection 1 1
Vascular Dissection 1 1
No Patient Involvement 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 Dec-23-2024
2 MEDLINE INDUSTRIES, LP - Northfield II Mar-29-2024
3 Sklar Instruments II Jan-16-2025
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