<prompt> Fingqa isihloko: CNN I-CNN iye yathola ukuthi umenzi we-endoscope owahileleka ekubulaweni kwama-superbug amabili e-UCLA akakaze athole imvume yokuthengisa le divayisi, ngokusho kwesikhulu se-Food and Drug Administration. I-Olympus yaqala ukuthengisa i-duodenoscope yayo i-TJF-Q180V ngo-2010, kodwa i-FDA ayizange ikuqaphele kwaze kwaba sekupheleni kuka-2013 noma ekuqaleni kuka-2014 ukuthi le nkampani ayikaze icele imvume yokuyifaka emakethe, ngokusho kukaKaren Riley, iphini lomqondisi wecebo leHhovisi Lezindaba Zangaphandle le-FDA. Kungani singakuqaphelanga? Angazi, kusho uRiley. UDkt. Steven Nissen, umphathi wezokwelapha ngezifo zenhliziyo eCleveland Clinic, oye wafakaza phambi kweCongress ngezinkinga zokuphepha kwalezi zinto, wabuza: Ungazibona yini ngeso lengqondo umuthi odayiswa ngemithi yezokwelapha usungathengiswa ngaphandle kokuthola imvume? Kumelwe kulawulwe ngokuqinile amadivayisi. Lokhu kuyasikhathaza ngempela. Esitatimendeni, i-Olympus yathi yayingacabangi ukuthi idinga imvume ye-FDA yokuthengisa le divayisi, kodwa manje ngesicelo se-ejensi, iye yafaka isicelo saleyo mvume. Leso sicelo sisalindile. Iziguli eziyisikhombisa zesibhedlela saseRonald Reagan UCLA Medical Center zatheleleka nge-superbug ebulalayo i-CRE - eyaziwa nangokuthi i-Enterobacteriaceae emelana ne-carbapenem - kusukela ngo-Okthoba kuya kuJanuwari, ngokusho kwezikhulu zesibhedlela. Iziguli ezimbili zafa. Iziguli zathola i-CRE ngemva kokwelashwa okuvamile kwe-endoscopic. Iziphathimandla zesibhedlela zikholelwa ukuthi imishini emibili yezokwelapha eyayisaphethe amagciwane abulalayo ngisho nangemva kokuba iziqondiso zokubulala amagciwane sezilandelwe yiyona eyabangela ukuqubuka kwalezi zinambuzane ezinkulu. Lesikhungo sezokwelapha siye saxhumana nabanye abangu - 179 abahlolwa nge - endoscope phakathi kuka - October no - January futhi sibanikeza ukuhlolwa kwasekhaya ukuze kuhlolwe amagciwane. Ezinye iziguli ezine eCedars-Sinai Medical Center eLos Angeles nazo ziye zangenwa yileli gciwane elihlobene ne-duodenoscope engcolisiwe, ngokusho kwesitatimende esikhishwe yisibhedlela. Lolu hlu lwezokwelapha lwalusetshenziswa kuzo zonke iziguli ezine, phakathi kuka-August noJanuwari 2015. Ezinye iziguli ezingamashumi ayisithupha nane ezaba...  <response>: Isikhulu se-FDA sithi i-Olympus ayikaze ithole imvume yokuthengisa i-endoscope yayo. Idivayisi yezokwelapha ixhunyaniswe nokuqubuka kwe-CRE eCalifornia okushiye abantu ababili befile. 