A1: patient identifier: requested, not provided.A2: age & date of birth: requested, not provided.A3: patient sex: requested, not provided.A4: weight: requested, not provided.A5: ethnicity: requested, not provided.A6: race: requested, not provided.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: operations manager.1.Since the actual sample was not returned, investigation of it could not be performed.2.Review of the manufacturing record and the shipping inspection record of the involved product code/lot# confirmed that there was not any anomaly in them.3.A search of the complaint file found no other similar report of the product with the involved product code/lot number from other facilities.4.Udi no.(b)(4).(cause of occurrence).Based on the investigation result, no anomaly was found in the manufacturing record and the shipping inspection record.However, since the actual product was not returned and investigation could not be performed, it was not possible to clarify the cause of occurrence.(countermeasure).Ashitaka factory assures the quality of this product by performing following controls.The guidewires is passed through the dedicated tool on 100% basis to confirm that there is no peeling of the outer layer or adhesion of any foreign substances on the surface of guidewire.Before the packaging process, 100% visual inspection is performed to confirm that there is no anomaly in the appearance such as exposure of core or scratch on the surface.This report is for the second device reported, for the first device reported that was used on the same patient see mdr 9681834-2023-00175.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.
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