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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device insufflator, hysteroscopic, fluid, closed-loop recirculation with cutter-coagulator, endoscopic, bipolar
Definition to distend the uterus with saline and maintain distension through closed-loop recirculation of filtered distension fluid during diagnostic and operative hysteroscopy. It is also intended for cutting and coagulation of uterine tissue.
Product CodePGT
Regulation Number 884.1710
Device Class 2

Device Problems
Communication or transmission issue 7
No Known Device Problem 3
Device inoperable 3
Connection issue 2
Tear, rip or hole in device packaging 1
Burn of device or device component 1
Leak 1
Material separation 1
Total Device Problems 19

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