NI

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED A FLOW COUPLER LOST THE FLOW SIGNAL FROM THE MONITOR. THE PATIENT HAD UNDERGONE A BILATERAL BREAST RECONSTRUCTION WITH DEEP INFERIOR EPIGASTRIC PERFORATOR ARTERY (DIEP) FLAP TISSUE TRANSFER USING FLOW COUPLERS FOR POST-OPERATIVE VENOUS FLOW MONITORING. AFTER AN UNKNOWN TIME POST OPERATIVE, THE FLOW COUPLER LOST THE FLOW SIGNAL FROM THE MONITOR. THE INTENSIVE CARE (ICU) NURSE NOTED ¿THE WIRE INTO THE HUB AT THE CONNECTION POINT TO THE EXTENSION CORD HAD BROKEN¿ AND INTERRUPTED THE SIGNAL. THE PHYSICIAN DETERMINED THE PATIENT REQUIRED A RETURN TO THE OPERATING ROOM TO REPLACE THE WIRE AND DOPPLER PROBE. THE DOPPLER SIGNAL WAS RESTORED AND THE PATIENT RETURNED TO THE ICU FOR NORMAL POST-OP RECOVERY. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9, H3, H6 AND H11. H11: THE DEVICE WAS RECEIVED FOR EVALUATION. THE PRODUCT WAS RETURNED IN A BIOHAZARD BAG WITH ONLY THE ADAPTER PRESENT. DURING VISUAL INSPECTION DAMAGE WAS DETECTED. THE WIRE PROBE WAS SEPARATED; THIS IS CONSISTENT WITH THE REPORTED STATEMENT OF "CORD HAD BROKEN." THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED; HOWEVER, THE MOST PROBABLE CAUSE WAS DUE TO UNDUE PRESSURE PLACED ON THE PROBE WIRE DURING PREPARATION FOR THE SURGICAL PROCESS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.