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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device electrosurgical patient return electrode
Regulation Description Electrosurgical cutting and coagulation device and accessories.
Definition Ground pad used to finish circuit during electrosurgery. A single use, non-sterile dispersive electrode with a pre-attached cord used to adhere to the patient over the entire pad surface to complete the electrosurgical circuit between the generator, the active electrode, and the patient.
Product CodeODR
Regulation Number 878.4400
Device Class 2

MDR Year MDR Reports MDR Events
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Superficial (First Degree) Burn 1 1

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