Description of Event or Problem · 1
DR USED "SMALL STAINLESS STEEL DONUTS", WHICH THEIR SPOUSE MADE AT HOME, TO SECURE A SPLITING TUBE IN A 03/2003 SURGERY. TWO MONTHS LATER THE PT HAD TO HAVE ANOTHER SURGERY TO REMOVE THESE STAINLESS STEEL DEVICES. FOUR MONTHS LATER THE QUALITY/RISK MANAGEMENT DIRECTOR BECAME AWARE THAT THE DEVICES WERE USED AND THAT THEY WERE NOT OBTAINED THROUGH THE HOSPITAL'S NORMAL VENDOR SUPPLIER PROCEDURE AND THAT THE DOCTOR DID NOT SEEK APPROVAL OF MANUFACTURED DEVICES THROUGH MEDICAL STAFF AND ADMINISTRATIVE/RISK MANAGEMENT. HOSPITAL CONTACTED DEPT OF HEALTH WHO DETERMINED THAT THE HOSPITAL TOOK APPROPRIATE ACTION UPON LEARNING OF THE DEVICES USED AND INSTRUCTED HOSPITAL TO LET FDA KNOW OF THE DOCTOR'S PRACTICES IN CASE OF FUTURE DEVICE MANUFACTURING PRACTICES.