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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stylet, surgical, general & plastic surgery
Product CodeGAH
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2019 3 3
2020 1 1
2021 2 2
2022 7 7
2023 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 9 9
Material Fragmentation 7 7
Break 4 4
Failure to Read Input Signal 1 1
Use of Device Problem 1 1
Connection Problem 1 1
Detachment of Device or Device Component 1 1
Material Integrity Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 17 17
No Known Impact Or Consequence To Patient 2 2
Unspecified Tissue Injury 2 2
Hematoma 1 1
Visual Impairment 1 1
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 CLINICAL LASERTHERMIA SYSTEMS AB II Jun-04-2021
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