CORE TRUMPET 5X32CM 1 OR 2 BAG

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED BY THE USER FACILITY THEREFORE IS UNABLE TO BE EVALUATED. A REVIEW OF MANUFACTURING DOCUMENTS WAS NOT POSSIBLE AS THE LOT NUMBER FOR THIS PRODUCT WAS NOT MADE AVAILABLE. A HISTORICAL REVIEW OF COMPLAINT DATA REVEALED ONE COMPLAINT IN THE PAST TWO YEARS. IN THE SAME TIMEFRAME (B)(4) UNITS HAVE BEEN SOLD WORLDWIDE, MAKING THE RATE OF OCCURRENCE OF THIS FAILURE (B)(4) PERCENT. THE SEVERITY OF THIS ISSUE WILL NEED TO BE RE-EVALUATED. THIS COMPLAINT HAS BEEN ESCALATED TO DETERMINE IF FURTHER INVESTIGATION IS REQUIRED. IF RELEVANT INFORMATION IS GATHERED REGARDING THIS INCIDENT, THE RECORD WILL BE RE-OPENED AND A FOLLOW-UP REPORT WILL BE FILED. THE REPORTED FAILURE WILL CONTINUE TO BE TRACKED AND TRENDED THROUGH THE COMPLAINT SYSTEM.

Description of Event or Problem

DURING A LAPAROSCOPIC SPLENECTOMY, THE SURGEON REPORTED HAVING ISSUES WITH THE SUCTION BUTTON OF THE CORE SUCTION IRRIGATION. THE SUCTION BUTTON OF THE HANDPIECE KEPT BECOMING DEPRESSED DURING THE CASE, RESULTING IN INFERIOR SUCTION. WHEN A VESSEL WAS CUT DURING THE PROCEDURE BLEEDING OCCURRED AND, DUE TO INFERIOR SUCTION OF THE REPORTED DEVICE, VISIBILITY WAS COMPROMISED. TO CONTROL THE BLEEDING, THE PROCEDURE WAS CONVERTED FROM LAPAROSCOPIC TO AN OPEN PROCEDURE. TO DATE, NO PATIENT STATUS INFORMATION HAS BEEN PROVIDED. THIS REPORT IS RAISED ON THE BASIS OF A REPORTED PATIENT INJURY.