Events

Reamer/lrrigator/Aspirator (RIA) 에 대한 현장 안전성 서한

Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI)에 따르면, 해당 현장 안전성 서한 는 Slovenia 에서 Synthes GmbH 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Field Safety Notice
  • 날짜
    2015-07-01
  • 사례 국가
    Slovenia
  • 사례 출처
    AMPMDRS
  • 비고 / 경고
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • 데이터 추가 비고
  • 원인
    Precautionary statements are being added to the “reamer/ lrrigator / aspirator (ria) surgical technique guide". it was reported that the ria drive shaft, tube assembly, and reamer head have the potential to break when incorrectly assembled or used improperly.

Device

Reamer/lrrigator/Aspirator (RIA)
  • 모델명 / 제조번호(시리얼번호)
    RIA Drive Shaft, length 360 mm 314.742 RIA Drive Shaft, length 520 mm 314.743 RIA Tube Assembly, for RIA Drive Shaft 314 7458 minimum length 360 mm. for No. 314.742. sterile ' RIA Tube Assembly, for RIA Drive Shaft 314 7468 minimum length 520 mm. for No. 314.743, sterile ‘ RIA Medullary Reamer Head 0 12.0 mm, sterile 352.2508 RIA Medullary Reamer Head i3 12.5 mm, sterile 352.2518 RIA Medullary Reamer Head D 13.0 mm, sterile 352.2528 RIA Medullary Reamer Head I2 13.5 mm, sterile 352.2538 RIA Medullary Reamer Head 9 14.0 mm. sterile 352.2548 RIA Medullary Reamer Head 0 14.5 mm, sterile 352.2558 RIA Medullary Reamer Head 9 15.0 mm. sterile 352.2568 RIA Medullary Reamer Head 2 15.5 mm. sterile 352.2578 RIA Medullary Reamer Head 0 16.0 mm, sterile 352.2588 RIA Medullary Reamer Head (3 16.5 mm. sterile 352.2598 RIA Medullary Reamer Head (25 17.0 mm. sterile 352.2618 RIA Medullary Reamer Head 9 17.5 mm. sterile 352.2628 RIA Medullary Reamer Head 0 18.0 mm. sterile 352.2638 RIA Medullary Reamer Head 0 18.5 mm, sterile 352.2648 RIA Medullary Reamer Head D 19.0 mm, sterile 352.2658
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH