FDA-Device2021-11-24Class II
Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05
CooperSurgical, Inc.
Hazard
Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any intraoperative bleeding and complete the case.
Sold states
US Nationwide Distribution Foreign: ARMENIA, BOLIVIA, CAMBODIA, CANADA, CHILE, CHINA, COSTA RICA, DOMINICAN REPUBLIC, ECUADOR, ENGLAND, GERMANY, HONG KONG, INDIA, INDONESIA, IRAN, ITALY, JORDAN, KENYA, MALAYSIA, MAURITIUS, MEXICO, NEW ZEALAND, NICARAGUA, NIGERIA, PHILIPPINES, PUERTO RICO, QATAR, RWANDA, SINGAPORE, SOUTH AFRICA, SRI LANKA, TAIWAN, TANZANIA, THAILAND, TRINIDAD, TURKEY, UGANDA, UNITED ARAB EMIRATES, VIETNAM
Affected count
700 Units
Manufactured in
95 Corporate Dr, N/A, Trumbull, CT, United States
Products
Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0262-2022Don't want to check this manually?
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