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HomeNATIONAL ADVANCED ENDOSCOPY DEVICES, INC. › TRU-VU MINI TROCAR/CANNULA 4.0MM, 15CM

TRU-VU MINI TROCAR/CANNULA 4.0MM, 15CM

NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Model MT4015 · UDI-DI 00848657075763

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

Description

An atraumatic, invasive, hand-operated tube designed as a conduit for irrigation and aspiration (i.e., capable of both functions) of body cavities/wounds during a surgical procedure (e.g., neurosurgery, laparoscopy), typically to facilitate observation. It might incorporate a handle with a valve(s) and hole(s) on its side for the control of irrigation/aspiration, and may be provided with a stylet, a sheath, and/or connection tubing; it is typically made of metal.

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.