MalfunctionDXX
CORPATH GRX SYSTEM
Received Jul 9, 2020 · Event occurred Jun 12, 2020
Report 3007822508-2020-00003 · MDR key 10254445
Device
Product problems
- Thermal Decomposition of Device
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
CORINDUS SERVICE PERSONNEL INVESTIGATED THE PROBLEM AND FOUND A BURNT CABLE INDICATING A POSSIBLE ELECTRICAL SHORT. NO PATIENT INVOLVEMENT. THERE WAS NO PATIENT OR OPERATOR INJURY DUE TO THE ISSUE. THE INITIAL INVESTIGATION HAS NOT BEEN ABLE TO DUPLICATE ANY FAILURES. THE ISSUE WILL BE MONITORED AND TRENDED IN FUTURE COMPLAINTS.
Description of Event or Problem
SUSPECT WIRING ISSUE AS ROBOTIC DRIVE CONNECTOR HAS A BURN MARK.
Remedial action
- Repair