Description of Event or Problem · 1
ON (B)(6) 2010, MY WIFE, (B)(6) HAD AN ENDOSCOPIC CAPSULE CAMERA GIVEN ORALLY TO EXAMINE GENERAL DIGESTIVE PROBLEMS THAT SHE HAS BEEN ENCOUNTERING FOR SOME TIME. ON (B)(6) 2010, SHE ENTERED (B)(6) ER WITH A SUSPECTED TIA. AN X-RAY NOTED THE ABOVE CAPSULE - MFG BY OLYMPUS AMERICA, INC - LODGED IN HER LOWER COLON. A DEFINITIVE MRI COULD NOT BE DONE CONCERNING THE TIA FOR FEAR OF MAGNETIC EFFECTS ON THE CAPSULE AND INTERNAL DAMAGES. ON (B)(6) 2010, MRS (B)(6) UNDERWENT AN UPPER GI AT (B)(6) HOSP AND THE TEST DETERMINED THAT THE CAPSULE WAS STILL IN THE SAME POSITION IN THE LOWER COLON--THE ILEUS I BELIEVE. MRS (B)(6) IS TOO FRAGILE TO UNDERGO SURGERY AT THIS TIME FOR REMOVAL SO, WE ARE LOOKING FOR ADVICE FROM ALL CONCERNED, PARTICULARLY OLYMPUS AS TO FREQUENCY OF SUCH INCIDENTS, TIME ELAPSED ON SUCH LODGINGS, THE POSSIBILITY OF THE CAPSULE DISSOLVING OVER TIME AND WILL ANY COMPONENT PARTS HARM THE SYSTEM IF IT DOES DISSOLVE OR BEGIN TO ERODE? SINCE IT HAS BEEN LODGED FOR ABOUT 10 MONTHS, ARE THERE ILL-EFFECTS WE SHOULD WATCH FOR? ALSO, WHEN WAS THIS CAPSULE LAST TESTED BY FDA TRACKING PROCEDURES? ANOTHER PROBLEM FOR HER IS, SHOULD SHE HAVE ANOTHER TIA, AN MRI CANNOT BE USED TO FURTHER EXAMINE FOR STROKE, ETC BECAUSE OF THE DRAMATIC MAGNETIC EFFECT. IS A CT SCAN EQUALLY DEFINITIVE? IT CERTAINLY SEEMS WE ARE IN BETWEEN A ROCK AND A HARD PLACE.