FDA Adverse Event Injury Summary report: N

EVIS EXERAII BRONCHOVIDEOSCOPE

MDR report key: 8947747 · Received August 29, 2019

Report

Report Number
2951238-2019-01070
Event Type
Injury
Date Received
August 29, 2019
Date of Event
June 5, 2019
Report Date
August 29, 2019
Manufacturer
OLYMPUS MEDICAL SYSTEMS CORP.
Product Code
EOQ
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
SC, US
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL

Narratives

Description of Event or Problem · 1

THE USER FACILITY REPORTED THAT 70 BRONCHOSCOPIES WERE PERFORMED DURING THE MONTH OF (B)(6) 2019, USING THREE OF THE FACILITY¿S BRONCHOSCOPES. OF THAT, FOUR PATIENTS TESTED POSITIVE FOR ACHROMOBACTER XYLOSOXIDANS DENITRIFICANS. THE FIRST PATIENT WAS PREVIOUSLY ADMITTED TO THE FACILITY ON (B)(6) 2019 AND UNDERWENT BRONCHOSCOPY TWO DAYS LATER. THE PATIENT REMAINED HOSPITALIZED AND WAS DISCHARGED (B)(6) 2019. THIS PATIENT WAS READMITTED TO THE FACILITY (B)(6) 2019 POST A THIRD BRONCHOSCOPY PROCEDURE AND WAS DISCHARGED (B)(6) 2019. ACCORDING TO THE USER FACILITY, THE PATIENT¿S MEDICAL RECORDS SHOWED THIS PATIENT TESTED POSITIVE FOR THE ACHROMOBACTER XYLOSOXIDANS DENITRIFICANS AFTER EACH PROCEDURE. THE PATIENT RECEIVED CONSULT WITH INFECTIOUS DISEASE (ID) AND WAS TREATED WITH ANTIBIOTICS ORDERED BY PULMONOLOGIST. THE USER FACILITY BELIEVES THAT THE PATIENT BEING IMMUNOCOMPROMISED IS A CONTRIBUTORY FACTORY. ADDITIONALLY, THE USER FACILITY REPORTED THAT FROM AUGUST 9, 2019 THRU AUGUST 12, 2019 SAMPLES WERE TAKEN FROM FACILITY¿S SCOPE CABINET, SINK TAP WATER, CLEAN SINK DRAIN, DIRTY SINK DRAIN, ENZYMATIC CLEANER, OER PRO SUPPLY WATER, SUPER SANI WIPES PDI, ALCOHOL CAP OER PRO, DETERGENT CAP OER PRO, PROVON SOAP DISPENSER HALL SCRUB SINK, CHLOREX DISPENSER HALL, SCRUB SINK AND 10 ML SALINE FLUSHES FROM THE THREE SCOPE CHANNELS (SERIAL NUMBERS: 2701245, 2500053 AND 2902731). ALL SAMPLES WERE NEGATIVE FOR THE ACHROMOBACTER ORGANISM. THIS REPORT IS TO ACCOUNT THE FIRST PROCEDURE FOR PATIENT ONE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
739649 EVIS EXERAII BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORP. BF-Q180

Patients

Seq Age Sex Outcome Treatment
1 64 YR Hospitalization| R