V5Ms transesophageal transducer 의 안전성 경고

Safety alert

2014-09-03

2014-09-02

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20140903.html

Medical device safety alert: siemens v5ms transesophageal transducer medicines and healthcare products regulatory agency (mhra), united kingdom, has issued a medical device safety alert concerning v5ms transesophageal transducer, manufactured by siemens ltd. the affected serial numbers range from 32800000 to 42300000. the manufacturer has received recent reports about the deterioration of material covering the articulating section of the v5ms transesophogeal transducer.A compromise or fault in this material combined with a failure to use a probe cover as directed in the user manual may cause esophageal cuts, bleeding, and perforation to the patient, and severe trauma, electrical burns, and serious electrical hazards to the patient and the user. however, a leakage current test can indicate cracks, cuts, tears, perforations, and protrusions in the articulation material. the potential risk is avoided only if users perform the recommended leakage current test of the transesophageal transducer prior to each use. the manufacturer advises users to undertake the following steps to avoid the potential risk of this issue: perform the leakage current test for a transesophageal transducer prior to each use. use only the manufacturer approved cleaning and disinfecting solutions. use market-cleared transducer sheaths specifically designed for transesophageal echocardiogram (tee) applications. when users store the transesophageal transducer, take extreme care that the distal tip is straight. never move the distal tip by hand. always use the flex controls. the manufacturer advises customers that if they notice any damage or wear on the transducer, or if the transducer fails to pass the leakage current test, they should immediately discontinue use of the transducer and contact the manufacturer. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con448384 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 2 september 2014.