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Association of Indian Medical Device Industry (AIMED)
Abstracts Of Regulatory Report – July 2011
Siemens Medical Solutions USA, Inc. - Acuson S2000
Safety issue fix for VB10, VB10A, VB10B, VB10C systems.
Measurement results from a previous study containing a patient report may be
merged to the next patient study.
Smith & Nephew, Inc., Endoscopy Division - Dyonics Power
Shaver Blade-Full Radius; Dyonics Power Shaver Blade-Full Radius, Curved, Convex
Smith & Nephew has identified an issue with insufficient weld
penetration which joins the shaft tube and blade tip. This may cause the blade
tip to separate from the tube shaft during use.
Stryker Endoscopy - Instruction for use for 45cm
Laparoscopic; Instruments Sterilization Trays
During a review and retest of the sterilization parameters,
Stryker Endoscopy discovered that the 132OC gravity steam sterilization cycle
did not consistently sterilize all of the products in the tray.
Vascular Solutions, Inc. - Langston Dual Lumen Pigtail
Catheter Model 5515
Addition of the Langston Dual-Lumen Pigtail Catheter, model
5515 lot# 548264 to the scope of the previous field action
2134812-08/31/2010-001R as having a missing sterile barrier pouch seal.
Vitalaire Canada Inc. - EZ-OX Plus Oxygen Regulator
One customer reported sudden and rapid emptying of an oxygen
cylinder with the EZ-OX Plus Oxygen Regulator. This was detected by the audibly
loud noise of a pressurized cylinder emptying rapidly.
W&H Dentalwerk Burmoos GMBH - Vinci 600 System -
Reciprocating Saw
Following a complaint concerning the reciprocating saw
attachment V600 SR (ref: 17306210), extensive tests have shown that in some
cases screws can become loose or might even come off (the attachment).
William A. Cook Australia, PTY. Ltd. - Cook Sydney IVF
Hyaluronidase Kits
Two lot numbers recalled in Canada due to the receipt of
information that hyaluronidase material of incorrect origin was used in the
manufacture of the device.
Zimmer Inc. – Contoured Small Blade
Zimmer is initiating a recall of certain lots of the Zimmer
Contoured Small Blade instrumentation because the instruments within these lots
contain a protruding weld that may prevent the blade from sliding onto the
corresponding retractor frame as intended.
Zimmer Inc. – NexGen Complete Knee Solutions (CKS)
Zimmer is initiating a recall of certain lots of NexGen
Complete Knee Solution (CKS) posterior referencing instruments (PRI) because
they have a potential for exhibiting a breakdown of the aluminum/titanium
nitride PVD black coating. The NexGen PRI utilizes this coating as a cosmetic
means to depict points of attachment or adjustment of the instruments.
Zimmer Inc. - Versys Advocate Hip System, Femoral Stem;
Versys Advocate Hip System, Femoral Stem, Extended Offset
Certain lots of the Versys Advocate Hip System (Femoral Stem
Cemented) may contain an incorrect proximal centralizer packaged with the stem.
The centralizer packaged with these lots, if attempted to be used, may not mate
properly with the stem.
THE NEW UK BRIBERY ACT
The UK Bribery Act came into force on July 1st, enabling the
country to play a full part in tackling corruption.
They say the Act will allow Britain to tackle this serious
obstacle to trade and development without placing additional burdens on business
and legitimate enterprise. It introduces a corporate offence of failure to
prevent bribery by persons working on behalf of a business, and makes it a
criminal offence to give or offer a bribe and to request or accept a bribe
either in this country or abroad. Normal corporate hospitality will be largely
unaffected by the new Act.
LATEST UK MEDICAL DEVICE ALERTS.
a) 22 Jul 2011 Durewall handling belt supplied in the UK by
Prism Medical (MDA/2011/083). Issued due to the instructions for use (IFU) not
providing clear guidance on how to re-thread the buckle, nor the checks to be
carried out before each use.
b) 21 Jul 2011 HandyVac™ low vacuum surgical wound drainage
systems and accessories manufactured by Unomedical a/s (MDA/2011/082) Issued
because connector between the drainage tube and bellows may leak, resulting in
the loss of active drainage and an increased risk of infection and/or haematoma
formation requiring medical
intervention.
c) 18 Jul 2011 Ophthalmic surgical instrument - Cryomatic
probes manufactured by Keeler Ltd (MDA/2011/081). Issued because the
manufacturer issued a Field Safety Notice (FSN) but has not had sufficient
confirmation from users that they have received and acted on this information.
The issue is that the manufacturer has not validated the 134-137°C for three
minutes steam sterilisation method for the Cryomatic probes.
d) 14 Jul 2011 Invasive blood pressure monitoring (IBPM)
systems manufactured by Smiths Medical (MDA/2011/080), Issued because the
manufacturer issued a Field
Safety Notice (FSN) but has not had sufficient confirmation
from users that they have received and acted on this information. The issue
concerns reports of the tubing separating from the connectors resulting in leaks
or disconnections.
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