EGD ENDOSCOPE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-02 for EGD ENDOSCOPE manufactured by Olympus.

Event Text Entries

[39936257] On (b)(6) 2015, my gastro doctor performed a colonoscopy and endoscopy. The doctor scheduled many patients back to back. There wasn't much time between my scopes and the person before me. The scopes used were not cleaned properly or were not able to be cleaned properly. The scopes were as follows: olympus egd endoscope and olympus pedi colonoscope. Following the procedures, i became extremely ill and after 3 emergency room visits, was hospitalized for 4 days. The dirty endoscope caused a severe infection in my throat/esophagus from my collar bone to my tonsils. The growth was white with pus. The dirty scope and procedure also caused aspirations/ pneumonia in my left lung. Antibiotics were changed 3 times and i eventually had to be put on brain cancer antibiotics which finally begain to cure the throat/esophagus infections. Because of the aspiration/pneumonia, i am still on a nebulizer as my breathing has not returned to where it was before the procedures. The colonoscopy equipment caused severe abdominal pain for months following the procedure. The doctors were so focused on the illnesses from the endoscope, they did not focus on the abdominal issues from the colonoscopy. I will be seeing a new gastro doctor soon to see if the colonoscopy gave me an infection as well. It was medically necessary for me to have these procedures due to gastritis/heartburn. As patients, we put our faith in the doctor and in the equipment and trust that the equipment can be cleaned 100% and will not cause infection. It is very upsetting that two procedures caused such distress. It is my understanding that other scopes by olympus have been recalled and have been reported to have caused deaths/illnesses. This company needs to be held accountable as even the newer scopes such as used on me cannot be fully cleaned, therefore putting the patient at risk for serious injury. Please immediately pull one of these scopes and see if it can be cleaned to 100% and if not, recall them all. This needs to be done with every single scope from every manufacturer to prevent people suffering such as i did. Lastly, (b)(6) medical center needs to be investigated.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5060760
MDR Report Key5483077
Date Received2016-03-02
Date of Report2016-03-02
Date of Event2015-05-18
Date Added to Maude2016-03-07
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameEGD ENDOSCOPE
Generic NameEGD ENDOSCOPE
Product CodeGCQ
Date Received2016-03-02
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No0
Device Event Key0
ManufacturerOLYMPUS


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention; 3. Deathisabilit 2016-03-02

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