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AED

NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Model 92020-H · UDI-DI 00848657014359

NWV Prescription
0
510(k) clearances
508
Adverse events
7
Recalls
78
Facilities

Description

AED Light Weight Axial Handle for Needle Holder

Recalls

DateFirmReason
2020-03-17Applied Medical Resources CorpThere may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to tissue damage.
2020-03-17Applied Medical Resources CorpThere may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to tissue damage.
2020-03-17Applied Medical Resources CorpThere may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to tissue damage.
2020-03-17Applied Medical Resources CorpThere may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to tissue damage.
2017-04-25Cook Inc.reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products
2015-12-01JosNoe Medical, Inc.Damage to package seals potentially compromising sterility.
2013-05-01Applied Medical Resources CorpApplied Medical is conducting a voluntary recall on specific lot numbers of its Epix and Direct Drive Laparoscopic Graspers. When the ratchet trigger is activated, if a great enoug

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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.