NI

Additional Manufacturer Narrative

D4: UNIQUE IDENTIFIER (UDI) #: THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN; THEREFORE, THE UDI NUMBER COULD NOT BE COMPILED. H11: 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 THE PROBE WIRE ¿BROKE¿ POST-OPERATIVELY ON AN UNKNOWN FLOW COUPLER. THE FLOW COUPLER WAS IMPLANTED DURING A DEEP INFERIOR EPIGASTRIC PERFORATOR ARTERY (DIEP) PROCEDURE FOR BREAST RECONSTRUCTION. AT SOME POINT IT APPEARS THE PROBE WIRE HAD BEEN PULLED OR BROKEN FROM THE PROBE CONNECTOR ON THE FC OR PATIENT SIDE OF THE CONNECTION. THIS RESULTED IN A LOSS OF THE SIGNAL TO THE FLOW COUPLER MONITOR. THE SURGICAL PROCEDURE INVOLVED A BURIED FLAP WHERE THE SIGNAL WAS DISRUPTED; THEREFORE, THE DOCTOR HAD NO ABILITY TO MONITOR THE FLAP. FOR THIS REASON, THE SURGICAL DECIDED TO RETURN THE PATIENT TO THE OPERATING ROOM TO REPLACE THE PROBE WIRE. AFTER THE SECOND OPERATION, THE SIGNAL WAS RESTORED AND THE PATIENT PROCEEDED ON A NORMAL COURSE OF RECOVERY. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: H6 AND H11. H11: 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.