MAUDE MDR 5483077

MDR report key
5483077
Report number
MW5060760
Event key
0
Event type
3
Date of event
2015-05-18
Date received
2016-03-02
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
0EGD ENDOSCOPEEGD ENDOSCOPEOLYMPUSGCQ* *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-03-0201. H; 2. R; 3. S

Event Narratives#

D

Patient 1

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.