Home › NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. › Hemo-Lock Articulating Tip Clip Applier X-Large Clips, 10mm X 33cm

Hemo-Lock Articulating Tip Clip Applier X-Large Clips, 10mm X 33cm

NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Model H1616XL-AT · UDI-DI 00848657070850

GDO Prescription

510(k) clearances

16,639

Adverse events (40 deaths)

Recalls

152

Facilities

Description

A hand-held manual surgical instrument designed to apply small atraumatic clips (not included) for the ligation of blood vessels, or similar tubular anatomy, mainly to prevent and/or stop bleeding during an open-surgery procedure.

Recalls

Date	Firm	Reason
2016-08-24	Teleflex Medical	Misbranded: Incorrect etching on the device.
2015-11-02	The Anspach Effort, Inc.	Assembled with the incorrect (smaller) front clips (component 44-0495 instead of 44.0498).
2013-04-12	Ethicon Endo-Surgery Inc	Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP 10mm M/L Endoscopic Rotating Multiple Clip Applier (ER320) due to potential clip formation and feeding issues whi
2013-04-12	Ethicon Endo-Surgery Inc	Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP 10mm M/L Endoscopic Rotating Multiple Clip Applier (ER320) due to potential clip formation and feeding issues whi
2013-04-12	Ethicon Endo-Surgery Inc	Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP 10mm M/L Endoscopic Rotating Multiple Clip Applier (ER320) due to potential clip formation and feeding issues whi
2004-06-07	Ethicon Endo-Surgery	This device is subject to recall due to an increased possibility of clip scissoring which can result in less than optimal clip formation which may or may not securely ligate tubula
2003-05-21	Weck	Some stylets were not bent sufficiently during the packaging process to preclude them from sliding back into the cannula during shipment.
2001-10-31	Weck	The flush port on some appliers was occluded with an epoxy resin during manufacturing.

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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.