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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
2020 6 6
2021 20 20
2022 18 18
2023 25 25
2024 20 20
2025 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Break 39 39
Difficult to Open or Close 8 8
Material Fragmentation 8 8
Detachment of Device or Device Component 5 5
Mechanical Problem 4 4
Improper or Incorrect Procedure or Method 3 3
Fracture 3 3
Material Integrity Problem 3 3
Defective Device 2 2
Device-Device Incompatibility 2 2
Material Separation 2 2
Crack 2 2
Entrapment of Device 2 2
Material Deformation 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Packaging Problem 2 2
Failure to Cut 1 1
Deformation Due to Compressive Stress 1 1
Contamination /Decontamination Problem 1 1
Component Missing 1 1
Device Reprocessing Problem 1 1
Degraded 1 1
Disconnection 1 1
Material Twisted/Bent 1 1
Mechanical Jam 1 1
Output Problem 1 1
No Apparent Adverse Event 1 1
Insufficient Information 1 1
Device Fell 1 1
Difficult or Delayed Separation 1 1
Inadequate Instructions for Healthcare Professional 1 1
Leak/Splash 1 1
Product Quality Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 59 59
Insufficient Information 12 12
Foreign Body In Patient 9 9
No Consequences Or Impact To Patient 4 4
Hemorrhage/Bleeding 4 4
Laceration(s) 3 3
Low Blood Pressure/ Hypotension 3 3
Tooth Fracture 2 2
Post Operative Wound Infection 2 2
Device Embedded In Tissue or Plaque 2 2
Pericardial Effusion 2 2
Respiratory Distress Syndrome of Newborns 1 1
Perforation of Vessels 1 1
Unspecified Infection 1 1
Unintended Radiation Exposure 1 1
Injury 1 1
Low Oxygen Saturation 1 1
No Patient Involvement 1 1
No Known Impact Or Consequence To Patient 1 1
Vascular Dissection 1 1
No Code Available 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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