Medical device manufacturer, Rudolf Medical GmbH, has issued a medical device safety alert concerning its laparoscopic instruments. The item numbers and descriptions of the affected products as follows:-
- RU 0385-xx and RU 0363-xx: Bended laparoscopic Inserts with tube (Ø 5.00 mm)
- RS 003-xx: Laparoscopic Inserts with tube ( Ø 3.00 mm)
- RS 002-xx: Laparoscopic Inserts with tube ( Ø 2.00 mm)
According to the manufacturer, a customer complaint brought to their attention that during reprocessing, the inner lumen of these laparoscopic inserts cannot be flushed out sufficiently with the recommended rinsing tip. Further investigation showed that all inserts, which cannot be disassembled – as listed above - are affected. Risk of infection exists.
The manufacturer advises users of the followings:
- For affected RU 0385-xx; Ø 5.00 mm
In order to prevent any further hazard issues, the manufacturer has redesigned the bended laparoscopic inserts. The improved version can be disassembled and therefore it can be cleaned effectively according the standard cleaning procedure for straight laparoscopic instruments.
The new design is more delicate and can therefore not provide as much tensile strength as the previous design. Users should be aware about this limitation of the new instruments.
In return of the old type of bended laparoscopic instruments, affected users will receive the redesigned insert version.
- For the affected RS 003-xx; Ø 3.00 mm
Since the laparoscopic instruments with Ø 3.00 mm are too thin for this type of redesign, the manufacturer will discontinue the 3.00 mm laparoscopic instruments for now in their portfolio, until they have developed an alternative, which can be disassembled.
In exchange, the manufacturer offers affected users the same type of inserts but in the size of Ø 3.50 mm. These laparoscopic instruments can be disassembled as well.
- For the affected RS 002-xx; Ø 2.00 mm
Since the laparoscopic instruments with Ø 2.00 mm are far too thin for this type of redesign, the manufacturer will cancel the 2.00 mm laparoscopic instruments for now from their portfolio, until an alternative, which can be disassembled, has been developed.
In exchange, the manufacturer offers affected users the dismountable laparoscopic instruments with Ø 3.50 mm.
Regardless of the time of purchase, any of the above mentioned laparoscopic inserts, which are returned, will be replaced with their alternatives.
According to the manufacturer, the affected products have been distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 06 December 2013