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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device resectoscope, working element
Regulation Description Endoscope and accessories.
Product CodeFDC
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 17
Tip breakage 9
Spark 9
Repair 5
Material fragmentation 3
Difficult to remove 3
Electrical issue 3
Use of Device Issue 3
Arcing 2
Fire 2
Component(s), broken 2
Normal 2
Intra-cavity procedure, fiberoptic break or fragmentation during 2
Inadequate service 2
Inappropriate shock 2
Device stops intermittently 2
Failure to service 1
Melted 1
Failure to cycle 1
Degraded 1
Burn of device or device component 1
Failure to Adhere or Bond 1
Electrode(s), fracture of 1
Energy output to patient tissue incorrect 1
Component missing 1
Device Issue 1
Device disinfection or sterilization issue 1
Device operates differently than expected 1
Device or device component damaged by another device 1
Output issue 1
No Information 1
Device handling issue 1
Total Device Problems 84

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