Surgical table 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 Mediland Enterprise Corporation. Linkou Factory. || Steris Corporation 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    I1606-237
  • 사례 연번
    2014DM-0012037
  • 날짜
    2016-06-03
  • 사례 국가
  • 사례 출처
    INVIMA
  • 사례 출처 URL
  • 비고 / 경고
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • 데이터 추가 비고
  • 원인
    The manufacturer has detected that there is a possibility that the pivot pin assembly on the surface of the table may become loose when the table is articulated, which could lead to the occurrence of potentially adverse events on patients or users.

Device

  • 모델명 / 제조번호(시리얼번호)
    OT1000, OT1100 and OT1200, specific serials.
  • 제품 설명
    The surgical table and table for surgery, are operating tables electrohydraulic, designed to carry out virtually all types of surgical procedures in cardiology, vascular surgery, cardiovascular, endoscopy, gynecology, urology, endurology, nephrectomy, neurology, neurosurgery, ophthalmology, orthopedics , abdominal, cystoscopy, thoracic and kidney, gallbladder, decay replacement, pacemaker insertions, HICKMAN catheters, BROVIAC insertions, shunts, VCI filters, cholangiographies, lung biopsies, implant defibrillation, NISSEN fundoplication; orthopedic reconstructive and hip repair procedures and lower extremities: total anterior hip proximal arthroplasty (AATHA); hip fracture; Tibial fracture; pelvic and acetabular fracture; fracture of the femur, thoracic and lumbar spine; arthroscopy and coating, implantation of nails in the hip, nailing of ENDER, intramedullary nails for femur, surgery of the tibia and elperoné. With the complement of the accessories of the table STERIS or MEDILAND. They allow the positioning and flexible articulation of the patient subjected to a surgical operation, designed specifically to offer the total flexibility of positioning of the patient that is required in modern surgical centers. They provide flexible and easy-to-use articulation mechanisms for patient positioning in reconstructive and restorative orthopedic procedures.
  • Manufacturer