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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device guide, needle, surgical
Regulation Description Manual surgical instrument for general use.
Product CodeGDF
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2021 9 9
2022 4 4
2023 13 14
2024 16 16
2025 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
Break 17 18
Difficult to Remove 9 9
Detachment of Device or Device Component 7 7
Device Contamination with Chemical or Other Material 7 7
Improper or Incorrect Procedure or Method 5 5
Image Display Error/Artifact 4 4
Device Markings/Labelling Problem 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Material Fragmentation 3 3
Migration or Expulsion of Device 2 2
Mechanical Problem 1 1
Failure to Eject 1 1
Difficult to Advance 1 1
Failure to Align 1 1
Material Twisted/Bent 1 1
Mechanics Altered 1 1
Migration 1 1
Failure to Advance 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 41 41
Foreign Body In Patient 9 10
Insufficient Information 6 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Pneumothorax 3 3
Hyperplasia 1 1
Pain 1 1
Perforation of Vessels 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Advance Medical Designs, Inc. II Sep-09-2023
2 M.D.L. S.r.l. II Sep-20-2021
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