Automated Leak and Electrical Validation for Electrosurgical Devices

Problem

Manual leak and electrical checks for electrosurgical probes created operator variability and risk of inconsistent defect detection.

Constraints

• Balloon leak detection required controlled inflation and decay monitoring.
• Electrical impedance and thermocouple response needed automated pass/fail criteria.
• Fixture and valve states had to prevent false failures and equipment damage.
• The station needed scalable production throughput.

Engineering Decisions

• Implemented an automated vapor generator sequence for leak and electrical checks.
• Used programmed pass/fail logic to remove subjective interpretation.
• Added valve-position checks and error-clearing logic to protect the test sequence.
• Structured output data around traceable serialized-unit results.

Validation

• Executed automated balloon inflation and decay checks.
• Verified impedance and thermocouple response against limits.
• Confirmed station interlocks and error states before production use.

Risk & Mitigation

• Micro-leaks could escape if decay limits were poorly defined; mitigated with automated pressure monitoring.
• False failures could occur from valve state errors; mitigated through state checks and error handling.
• Electrical faults could be missed by manual measurement; mitigated with automated sequence control.

Outcome

Automated inspection reduced operator variability, improved defect detection consistency, and supported traceable finished-device acceptance.