GENERAL PURPOSE PROBE,9FR SOFT, 400 SERIES, 9FR SOFT

Additional Manufacturer Narrative

A DISTRIBUTING FACILITY REPORTED, "A DISTRIBUTING FACILITY REPORTED, "DURING INTRAOPERATIVE TEMPERATURE MONITORING, THE PATIENT'S TEMPERATURE READINGS ON THE MONITOR WERE UNSTABLE. ALTHOUGH THE PATIENT'S ACTUAL TEMPERATURE WAS 36.2°C, THE MONITOR DISPLAYED VALUES OF 34°C TO 35°C EVERY FEW MINUTES DURING USE." DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE AND RECEIVED A PICTURE BUT HAS NOT YET RECEIVED IT. THIS INVESTIGATION IS NOT COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW UP REPORT WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

A DISTRIBUTING FACILITY REPORTED, "DURING INTRAOPERATIVE TEMPERATURE MONITORING, THE PATIENT'S TEMPERATURE READINGS ON THE MONITOR WERE UNSTABLE. ALTHOUGH THE PATIENT'S ACTUAL TEMPERATURE WAS 36.2°C, THE MONITOR DISPLAYED VALUES OF 34°C TO 35°C EVERY FEW MINUTES DURING USE."

Additional Manufacturer Narrative

A DISTRIBUTING FACILITY REPORTED, "A DISTRIBUTING FACILITY REPORTED, "DURING INTRAOPERATIVE TEMPERATURE MONITORING, THE PATIENT'S TEMPERATURE READINGS ON THE MONITOR WERE UNSTABLE. ALTHOUGH THE PATIENT'S ACTUAL TEMPERATURE WAS 36.2°C, THE MONITOR DISPLAYED VALUES OF 34°C TO 35°C EVERY FEW MINUTES DURING USE." DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE AND RECEIVED A PICTURE, BUT HAS NOT YET RECEIVED IT. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ASSEMBLY ISSUES WERE FOUND. USING SAMPLES RETURNED FROM OTHER SIMILAR COMPLAINTS, FUNCTIONAL AND DIMENSIONAL TESTING WAS CONDUCTED THAT DETERMINED THERE WAS AN INSTABILITY AT THE CONNECTOR SIDE. THROUGH FURTHER INVESTIGATION, IT WAS DETERMINED THAT A CRIMP SET DIFFERED BETWEEN THE OLDER MOLEX MACHINE AND NEW AUTOMATIC MACHINE. BECAUSE OF THIS DIFFERENCE, THERE WAS MORE PRESSURE APPLIED THAT CAUSED THE PIN TO DEFORM IN SOME CASES. IT WAS DETERMINED THAT THIS IS WHAT LED TO THE CONNECTOR INSTABILITY. A COMPLAINT TO SALES RATIO WAS CONDUCTED OVER THE PAST TWO YEARS AND FOUND TO BE 0.02%. ROOT CAUSE: THE ROOT CAUSE OF THE ISSUE WAS THE USE OF FACTORY-INSTALLED CRIMP SETS IN THE AUTOMATIC MACHINES WITH A PRESSING SURFACE WIDTH NARROWER THAN THE PIN WIDTH. THIS DIMENSIONAL INCOMPATIBILITY GENERATED EXCESSIVE LOCALIZED MECHANICAL STRESS DURING CRIMPING, RESULTING IN PIN DEFORMATION, ALTERED ELECTRICAL CONTACT GEOMETRY, AND SUBSEQUENT CONNECTOR INSTABILITY UNDER TEMPERATURE CONDITIONS. IMMEDIATE CORRECTIONS: CONSIDERING THAT THE IDENTIFIED ROOT CAUSE WAS CONNECTOR INSTABILITY CAUSED BY INSUFFICIENT ELECTRICAL CONTACT BETWEEN THE WIRE AND THE PIN, ALL PERSONNEL INVOLVED WERE INSTRUCTED TO INCORPORATE AN ADDITIONAL VERIFICATION STEP DURING FUNCTIONAL TESTING. THIS STEP CONSISTS OF GENTLY MANIPULATING THE CONNECTOR BY MOVING IT SLIGHTLY ONCE IN AN UPWARD AND DOWNWARD DIRECTION AND FROM SIDE TO SIDE, IN ORDER TO DETECT ANY POTENTIAL INTERMITTENT OR UNSTABLE CONDITIONS. ADDITIONALLY, THE SAMPLING PLAN APPLIED BY QUALITY CONTROL WAS ESCALATED FROM NORMAL INSPECTION TO TIGHTENED INSPECTION. AS A RESULT, THE SAMPLE SIZE PER BOX (2,000 UNITS PER BOX) WAS INCREASED FROM 20 UNITS TO 32 UNITS. THIS ADJUSTMENT WAS IMPLEMENTED TO STRENGTHEN DETECTION CAPABILITY, INCREASE PROCESS OVERSIGHT, AND REDUCE THE RISK OF ESCAPING UNSTABLE UNITS DURING THE CONTAINMENT PHASE. CORRECTIVE ACTIONS: THE AUTOMATIC MACHINE MANUFACTURER (KINGSING) AND THE LOCAL TOOL MANUFACTURER (MOTROSA) WERE CONTACTED. A DIMENSIONAL MODIFICATION OF ALL AUTOMATIC MACHINE CRIMP SETS WAS REQUESTED. POST IMPLEMENTATION OF THESE DIMENSIONAL MODIFICATIONS INDICATE A SUBSTANTIAL REDUCTION IN THE INSTABILITY RATES. DEROYAL WILL CONTINUE TO MONITOR FOR TRENDS AROUND THIS ITEM AND ISSUE. THE INVESTIGATION IS COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.