visera elite ii video system center olympus otv-s200 and otv-s300 의 안전성 경고

Safety alert

2018-06-21

2018-06-21

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20180621.html

Medical device safety alert: visera elite ii video system center olympus otv-s200 and otv-s300 medical device manufacturer, olympus, has issued a medical device safety alert concerning its visera elite ii video system center olympus otv-s200 and otv-s300 [serial number: 7700172, 7700627, 7700628, 7700734, 7700768, 7700899 and 7700901]. during the manufacturing process of the products, an unintended power shut down was noticed during a routine quality test. the failure has temperature dependency and may occur under environment of normal usage. therefore, it has decided to replace the power supply unit of the affected products with redesigned parts. according to the manufacturer, the products are surgical systems that are assumed to be used under environmental temperatures lower than twenty-five degrees celsius (25°c), the probability of remarkable declined exhaust heat efficiency due to dust accumulation is low and it is confirmed that operation of power supply will maintain its function unless the deterioration of the component is considerably advanced. therefore, the manufacturer surmised that the chance of occurrence for the power supply failure in the short term period is very low. there is no incidence of power shut down or patient injury has been reported during clinical usages so far. the manufacturer will contact the affected users and implement the corrective action plan to replace the power supply. the affected users can continue the usage of the products but, at the same time, it is recommended that another camera system be always kept as a standby. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 21 june 2018.