Analyze the following medical device risk scenario and provide a detailed FMEA assessment.
User Query:
Process: Endoscope Sterilization
Device Type: Endoscope
Potential Hazard: Incomplete sterilization
Potential Effect: Patient infection
Potential Cause: Equipment malfunction or human error
Process Name: Endoscope Sterilization
Device Type: Endoscope
Potential Hazard: Incomplete sterilization
Potential Effect: Patient infection
Potential Cause: Equipment malfunction or human error
Provide your analysis in the following JSON format without any additional text:
{
"hazard": "Specific hazard or failure mode identified",
"effect": "Potential effects on patient, user, or system",
"cause": "Potential causes of the hazard",
"occurrence": 1-10 (likelihood of occurrence, with 10 being most frequent),
"severity": 1-10 (severity of impact, with 10 being most severe),
"detection": 1-10 (difficulty of detection, with 10 being most difficult to detect),
"rpn": calculated Risk Priority Number (O × S × D),
"riskCategory": "high" | "medium" | "low" | "unclear",
"recommendations": ["Recommendation 1", "Recommendation 2", ...],
"reasoning": "Brief explanation of your assessment"
}
Important: Return ONLY the JSON object without any additional text, explanations, or markdown formatting.