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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device endoilluminator
Regulation Description Endoscope and accessories.
Product CodeMPA
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV
  SUBSTANTIALLY EQUIVALENT 1
ISCIENCE INTERVENTIONAL
  SUBSTANTIALLY EQUIVALENT 1
PEREGRINE SURGICAL LTD.
  SUBSTANTIALLY EQUIVALENT 5
STORZ
  SUBSTANTIALLY EQUIVALENT 1
SYNERGETICS, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Device displays error message 60
No code available 38
Loss of power 33
Inadequate lighting 16
Operating system becomes non-functional 10
Device stops intermittently 7
Device inoperable 6
Smoking 6
Unknown (for use when the device problem is not known) 5
Burn of device or device component 4
Delivered as unsterile product 3
Device emits odor 3
Other (for use when an appropriate device code cannot be identified) 3
Overheating of device or device component 3
Unsealed device packaging 3
Melted 2
Prompts will not clear 2
Temperature issue 2
No Information 1
No Known Device Problem 1
Device operates differently than expected 1
Bubble(s) 1
No device output 1
Material discolored 1
No display or display failure 1
Electrical issue 1
Failure to power-up 1
Suction issue 1
Total Device Problems 216

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