HOYA CORPORATION PENTAX Life care Division
** May 2014
Ref: FSCA-PMJ-14-01-1
FIELD SAFETY CORRECTIVE ACTION
PROPER USE OF ENDOSCOPIC ACCESSORIES WITH PENTAX
VIDEO GASTROSCOPES Gas/Water Feeding Valves
Models: OF-B130, OF-B194
To:
Customer address…
Attention:
Risk Manager
Urgent: Medical Device Field Safety Corrective Action
This notification is to inform you of the proper use of the lubricant oil (OF-Z11) applied on the, OFB130 and OF-B194 Gas/Water Feeding valves, supplied by PENTAX Medical.
The Pentax Brand Silicon Oil OF-Z11 must always be used for the O-rings of Pentax Gas/Water
Feeding valves.
In order to test the proper functioning of the valve you have to complete the following tests:
1. Attach the valve to the endoscope and test the functionality. If the valve does not function
properly (does not move smoothly, feels sticky, leak air or water) remove it and inspect for
worn or damaged O-Rings. Replace O-rings as necessary per the O-ring Instructions for Use
(IFU) and apply designated lubricant oil (OF-Z11) per the IFU.
2. Always apply a very small amount of the Pentax Brand Silicon Oil OF-Z11 to each rubber ORing on the PENTAX Valve mechanism.
DO NOT use excess oil, avoid blobs, large drops and/or squirts of oil directly onto the metal
valve stem-instead, simply place a small droplet of oil on one’s sterile gloved forefinger and
gently swirl between thumb and forefinger.
Next place the valve with O-ring in-between thumb and finger and gently rotate the valve so
that the oil is evenly applied to the outer edges of each rubber O-ring. Make sure the oil is
applied to all O-rings and wipe off all excess.
DO NOT apply excess oil. Doing so can allow for inadvertent migration of the oil inside
channels or other areas not intended to be lubricated.
3. In case the valve does not function properly during an examination, stop CO2 or water
supply at the primary valve ( i.e CO2 insufflator or CO2 bombe) immediately.
4. If the valve does not function properly, re-inspect the valve per step 1 and 2 above or use
another valve.
The information related to the usage of the lubricant oil OF-Z11 will be added to the next version of
the corresponding Instructions for Use of these valves.
Please be assured that maintaining the highest level of safety and quality is our foremost priority. If
you have any questions, please contact us immediately.
Sincerely,
{RQH name}
{Title and Company name}
{Department name}
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