ELEVATOR, PRESBYTERIAN HOSP, CURVED, DOUBLE ENDED

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED FOR EVAULATION. AFTER EVALUATION OF THE PARTS THAT WERE RETURNED, THERE IS AN IMPERFECTION IN THE PIN INSERT WELD AREA. THE DRAWING FILE WAS REVIEWED AND PER THE DRAWING NOTES THE WELDED TUNGSTEN CARBIDE INSERTS SHALL BE SMOOTH WITHOUT WELD PITS AND/OR JOINT GAPS. THE PARTS SHOWED JOINT GAPS IN THE INSERT AREA, AND THE ROOT CAUSE IS MANUFACTURING ERROR LINKED TO THE PRODUCTION PROCESSING DURING THE WELDING AND/OR FINISHING PHASE. THIS LOT WAS PRODUCED BY A SUPPLIER WHICH NO LONGER MAKES THIS PRODUCT FOR US, AND NEWER LOTS (FROM CURRENT SUPPLEIR) WERE CHECKED AND FOUND TO BE MADE CORRECTLY. THE CURRENT VENDOR WAS MADE AWARE OF THE COMPLAINT TO HELP PREVENT RECURRENCE. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

Additional Manufacturer Narrative

THE DEVICE HAS BEEN RETURNED FOR EVALUATION, AND THE INVESTIGATION IS ONGOING. ONCE WE HAVE ADDITIONAL RELEVANT INFORMATION IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

COMPLAINANT ALLEGES "PIN FELL OFF THE DEVICE AND INTO THE PATIENT, AND STAFF WAS ABLE TO RETRIEVE IT."