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Risk Management Risk Analysis
风险管理风险分析
Rev F
修订版 F
Title: VersaCut Tissue Morcellator Risk Analysis Matrix
标题：VersaCut组织粉碎器风险分析矩阵
Effective:
生效日期：
Per DMS
依据DMS
PURPOSE
目的
The purpose of this document is to provide a record and means of review of identified hazards and corresponding mitigation actions associated with the VersaCut Tissue Morcellator.
本文档旨在提供VersaCut组织粉碎器相关的已判定危害和相应缓解措施的审核记录和审核方法。
SCOPE
范围
This analysis is applicable to the VersaCut Tissue Morcellator and the associated accessories defined here.
该项分析适用于VersaCut组织粉碎器及本文档所规定的相关附件。
The following risk analysis file version is updated post product release
产品上市后，更新了下列风险分析文件的版本
Inputs for risk analysis update: VersaCut Morcellator Hazard Analysis Rev_B 2000, 0035-682-00_A VersaCut Tissue Morcellator RA, Morcellator Adverse Events List (up to Q3 2000), Morcellator ECOs list (SUR131-SUR1418), 2000 Q3 Complaints trending, 2000 AMTAC Audit comments, FDA alert regarding potential spread of canerous uterine cancer following morcellation
风险分析更新的输入：VersaCut粉碎器危害分析Rev_B 2000、0035-682-00_A VersaCut组织粉碎器RA、粉碎器不良事件列表(直至2000年第3季度)、 粉碎器ECO列表 (SUR131-SUR1418)、2000 Q3投诉趋势分析、2000 AMTAC 稽查意见、粉碎后子宫颈癌可能蔓延的FDA警示
PROCEDURE
程序
Index
索引
Section
节
Failure Modes
失效模式
Unintended tissue aspiration/ Morcellation.
非预期的组织吸引/粉碎。
Aspiration / Morcellation failure
吸引/粉碎故障
Design
设计
Hardware Design
硬件设计
Bio- contamination
生物污染
Software Design
软件设计
Electrical shock
电击
Process
过程
Labeling
标签
Unintended external harmful effect.
非预期的外部有害影响。
Service
服务
Use/Application
使用/应用
Over heating/Fire
过热/火灾
Training
培训
Final Testing
最终测试
This template was completed following the instructions and information provided in 34-00-00-00, Global Risk Management and according to the applicable standard ISO 14971:2000 / EN ISO 14971:2000 and AFAP (as far as possible) methodology
该模板遵照34-00-00-00“风险管理”所提供的说明和信息并依据适用标准ISO 14971:2000 / EN ISO 14971:2000和AFAP（尽量）原则填写。
Meetings of appropriate members of the IPT have been held in order to complete this analysis.
相关IPT成员已召开会议以完成该项分析。
Meeting attendees have been documented on form DS-0000620 , Meeting Attendance Form. 会议出勤情况已被记录到会议签到表DS-0000620。
Application of usability engineering to medical devices (IEC 62366:2000) is applied into this risk analysis.
标准“将可用性工程应用于医疗器械（IEC 62366:2000）”已被应用于该项风险分析。
VersaCut Tissue Morcellator Risk Analysis
VersaCut组织粉碎器风险分析
Mitigation is not required for any unmitigated risks that are found as a “Low” risks category.
若发现尚未缓解的风险属于“低”风险，则无需采取风险缓解措施。
The verification column is not applicable in this case.
在这种情况下，验证列不适用。
Essential Performance is defined as: Controlled start of morcellation and ability to stop morcellation.
基本性能的定义为：既能控制粉碎开始又能终止粉碎。
Operator Manual is exclusively provided in electronic form.
操作员手册完全以电子表格形式提供。
There is no additional unacceptable risk.
不存在其他不可接受风险。
Rational: Intended users are professionals, system is labled with symbol "Follow instructions for use".
依据：预期用户须为专业人士，系统标有“严格遵守使用说明”。
As such, users are expected to read Operator Manual before use.
用户在使用前同样应阅读操作手册。
Unmitigated Risk
尚未缓解的风险
Failure Mode
失效模式
Residual Risk
剩余风险
Hazard
危害
Resultant Harm
所造成的伤害
Cause
原因
Trigger event (cause)
触发事件（原因）
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