UNIVERSAL ACTIVE CORD

Description of Event or Problem

DURING USE OF A WILSON-COOK UNIVERSAL ACTIVE CORD, THE USER NOTED THAT THE CONNECTION TO AN ACCESSORY DEVICE WAS NOT SECURE. THE ELECTRICAL INSERT IN THE ACTIVE CORD HAS RECESSED, PROHIBITING PROPER CONNECTION WITH ATHE ACCESSORY DEVICE. ANOTHER ACTIVE CORD WAS USED TO COMPLETE THE PROCEDURE. AN INJURY TO THE PATIENT DID NOT OCCUR.

Additional Manufacturer Narrative

WE WERE UNABLE TO CONFIRM THE REPORT AS IT WAS DESCRIBED BECAUSE THE AFFECTED DEVICE WAS NOT RETURNED TO WILSON COOK FOR EVALUATION. AFTER A REVIEW OF THE DEIVCE HISTORY RECORD FOR THIS DEVICE, WE CAN REPORT THAT NO DISCREPANCIES OR ANOMALIES WERE OBSERVED. WE WERE UNABLE TO CONDUCT A SAMPLE TEST FROM THIS LOT, BECAUSE THE DEVICE HAD BEEN PREVIOUSLY DISTRIBUTED. CONCLUSION WERE WERE UNABLE TO CONDUCT A FULL INVESTIGATION, BECAUSE THE AFFECTED DEVICE WAS NOT RETURNED TO WILSON COOK FOR EVALUSTION. WE CAN PROVIDE THE FOLLOWING COMMENTS: THE ESTIMATED NUMBER OF USE FOR THIS DEVICE EXPERIENCED PRIOR TO THIS OCCURRENCE IS UNK. BECAUSE THIS DEVICE IS REUSABLE, IT IS POSSIBLE THIS OCCURRED AFTER SEVERAL USES. THE USEFUL LIFE OF A REUSABLE DEVICE IS DEPENDANT, IN LARGE PART, UPON THE CARE EXERCISED BY THE USER DURING USE AND GENERAL HANDLING. THIS DEVICE WAS NOT INVOICED TO THE USERE ON DECEMBER 2004. WILSON COOK RECEIVED THE REPORT ON JUNE 2005. CORRECTIVE ACTIONS: NO CORRECTIVE ACTION WARRANTED AT THIS TIME; THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED FOR THEIR AWARENESS. PRIOR TO DISTRIBUTION, ALL UNIVERSAL ACTIVE CORDS ARE SUBJETED TO A VISUAL AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY.