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AESCULAP

Aesculap AG · Model PO014R · UDI-DI 04038653284665

KNF Prescription

510(k) clearances

407

Adverse events

Recalls

Facilities

Description

POTTS-DE MARTEL MODIF. SAID ADTEC MONOPOLAR Vascular Scissors, complete instrument, monopolar, angled, working length: 12 1/4", (310mm), diam. 10 mm, sharp/sharp, rotatable, insulated, single action, consisting of PM992R, PO682R, PO958R, detachable, non-sterile,reusable, to be used with: PM941R

Recalls

Date	Firm	Reason
2013-02-12	Integra LifeSciences Corp.	Addendum to the Instructions for Use. The addendum emphasizes the warnings and precautions already contained in the device's IFU and also provides additional warnings and precautio
2012-05-23	Integra Limited	The Integra(TM) Jarit(R) Take-Apart Laparoscopic Instrument shafts were released with internal component out of specification.
2009-12-01	LINA Medical ApS	Potential for the LiNA Loop to break during operating procedure.
2009-12-01	LINA Medical ApS	Potential for the LiNA Loop to break during operating procedure.
2009-12-01	LINA Medical ApS	Potential for the LiNA Loop to break during operating procedure.

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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.