CONVATEC LOOP OSTOMY ROD

Description of Event or Problem

THE LOOP WAS USED ON THE MANIC PT. AFTER HE WOKE UP, HE PULLED THE SYSTEM (WAFER+POUCH+LOOP) OUT AND THE LOOP BROKE. THIS CASE IS NOT AN ADVERSE EVENT AS THERE WAS NO UNTOWARD EFFECT TO THE PT. THE ROD BROKE AND RECURRENCE COULD BE SERIOUS.

Additional Manufacturer Narrative

CONVATEC CONDUCTED A PRODUCT INVESTIGATION AND FOUND THE COMPLAINT "NOT CONFIRMED". 8 LOOP RODS WERE EXAMINED AND ALL SAMPLES WERE AS MFG IN SEALED PACKAGING. A VISUAL INSPECTION WAS PERFORMED ON EACH OF THE 8 RETURNED SAMPLES. THE RODS WERE FULLY ASSEMBLED, CLEAN AND FREE OF SPECKS AND BURN MARKS. THERE WERE NO INDICATIONS OF STRESS OR OTHER ANOMALIES VISIBLE UNDER X10 MAGNIFICATION. THERE WAS NO VISUAL EVIDENCE OF SPECKS, BURNS, CRACKS, FRACUTRES, GELS, VOIDS OR EXCESS FLASHING ON THE SAMPLES. SWIVEL OPERATION: THE SWIVEL ON EACH SAMPLE WAS ROTATED THROUGH 180 DEGREES TEN TIMES, EACH ONE OPERATED EASILY AND LOCATED POSITIVELY AT 90 DEGREES INTERVALS. THERE WAS NO DISLOCATION OF THE SWIVELS. THE SWIVELS WERE THEN DISLOCATED (TWISTED AND REMOVED) FROM THE LOOP ROD. THERE WAS NO PERMANENT DEFORMATION OR BREAKAGE AT THE END OF THE ROD. BATCH RECORD 4A76718 REVIEWED, NO EVIDENCE OF ANY NONCONFORMITIES / ANOMALIES RELATING TO THE SOURCE OF THE COMPLAINT OBSERVED.