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AESCULAP

Aesculap AG · Model PM407R · UDI-DI 04038653305100

HGI GEI Prescription

510(k) clearances

780

Adverse events

Recalls

Facilities

Description

METZENBAUM (MINI) ADTEC BIPOLAR Dissecting Scissors, complete instrument, bipolar, curved to left, working length: 12 1/4", (310 mm), diam. 5 mm, (14 mm), blunt/blunt, rotatable, insulated, double action, consisting of PM437R, PM450R, PM973R, detachable, non-sterile, reusable

Recalls

Date	Firm	Reason
2022-05-25	Mckesson Medical-Surgical Inc. Corporate Office	Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0
2021-09-29	CooperSurgical, Inc.	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 co
2021-09-29	CooperSurgical, Inc.	XXX
2021-09-29	CooperSurgical, Inc.	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 co
2021-09-29	CooperSurgical, Inc.	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 co
2021-09-29	CooperSurgical, Inc.	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 co
2021-09-29	CooperSurgical, Inc.	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 co
2021-09-29	CooperSurgical, Inc.	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 co
2019-10-16	CooperSurgical, Inc.	Potential for the Quantum 2000 Electrosurgery Generator, part numbers 909075, 909075-05 and 909075-05W, to cease to either cut, coagulate, or blend during a procedure when the foot
2019-10-16	CooperSurgical, Inc.	Potential for the Quantum 2000 Electrosurgery Generator, part numbers 909075, 909075-05 and 909075-05W, to cease to either cut, coagulate, or blend during a procedure when the foot

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.