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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device forceps, ophthalmic
Regulation Description Manual ophthalmic surgical instrument.
Product CodeHNR
Regulation Number 886.4350
Device Class 1

Device Problems
Break 23
Material Fragmentation 12
Particulates 6
Device Dislodged or Dislocated 4
Device Handling Problem 4
Defective Device 3
Adverse Event Without Identified Device or Use Problem 3
Material Separation 2
Inadequate Service 1
Metal Shedding Debris 1
Mechanical Jam 1
Detachment Of Device Component 1
Mechanical Problem 1
Misconnection 1
Cannula 1
Physical Resistance / Sticking 1
Detachment of Device or device Component 1
Device Operational Issue 1
Mechanics Altered 1
Difficult to Open or Close 1
Maintenance Does Not Comply To Manufacturers Recommendations 1
Total Device Problems 70


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