cystoscopy bridges and working inserts 의 안전성 경고

Safety alert

2017-08-08

2017-08-08

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20170808.html

Medical device safety alert: olympus cystoscopy bridges and working inserts medical device manufacturer, olympus, has issued a medical device safety alert concerning its cystoscopy bridges and working inserts. the affected devices are identified as follows:- model description: 1) working insert, with ramp, one way; 2) bridge, one way; 3) bridge, two way model numbers: 1) a20975a; 2) a20976a; 3)a20977a lot numbers: 1) n/a; 2) 152w, 154w, 157w, 16yw; 3) 151w, 152w, 153w the manufacturer has received complaints about fragments of adhesive which detached from inside the working channel of the referenced cystoscopy bridge models. cracking, chipping, missing pieces, and delamination of the adhesive have been observed. investigations have confirmed that this adhesive can detach during the intended use of the cystoscopy bridge or working insert, e.G. when inserting an instrument through the working channel. as a result, a fragment of the adhesive may fall inside the patient’s bladder or urethra and will need to be retrieved. although typically flushed out with irrigation fluid or passed naturally, the retrieval of large fragments of the adhesive could require additional surgical treatment. furthermore, the procedure can be prolonged resulting in extended anaesthesia. according to the manufacturer, there has been no report about an adverse event or patient injury related to this issue. the manufacturer will replace the devices completely. investigation results confirmed that these devices are safe to use until being replaced. users are advised to take the following actions:- inspect the inventory for the referenced devices and identify any of the specified model and lot numbers identified above. contact the manufacturer to schedule the successive return of all the affected devices for replacement and to arrange for temporary loan units if applicable. 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 8 august 2017.