Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI)에 따르면, 해당 현장 안전성 서한 는
Slovenia
에서 Greatbatch Medical 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.
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
On june 14, 2016 greatbatch medical identified an issue with the 00-7804-080-00 offset reamer
handle, as field complaints were reported that the drive chain mechanism seizes during use. the
function of the drive chain mechanism is to transmit rotational power from a mechanical drill to an
acetabular reamer during a total hip arthroplasty. during seizing, the device is rendered non-
functional in the operating room.
the risks associated with this failure are:
1. the offset reamer handle seizes and the surgery must be completed with an alternate
device, leading to a delay of 30 minutes or greater from the scheduled surgery time.
2. the offset reamer handle seizes and no replacement device is available in the hospital,
leading to an interruption and rescheduling of surgery. .