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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

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AIZU OLYMPUS CO., LTD. EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE Back to Search Results
Model Number GIF-H190
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Drug Resistant Bacterial Infection (4553)
Event Type  Injury  
Event Description
The customer reports three patients who underwent unspecified procedures using one of two different gastroscopes tested positive for a rare strain of antibiotic resistant e.Coli.The customer is unsure if the patients were cross infected with the scopes.Additional details regarding the patients and reported events have been requested.At this time, the only additional provided by the customer was that the scopes have been cultured by the facility.The cultures on both scopes have all come back negative, however, the scopes will be sent in for routine maintenance.Case with patient identifier (b)(6) reports patient one of three.Case with patient identifier (b)(6) reports patient two of three.Case with patient identifier (b)(6) reports patient three of three.
 
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Brand Name
EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
Type of Device
GASTROINTESTINAL VIDEOSCOPE
Manufacturer (Section D)
AIZU OLYMPUS CO., LTD.
3-1-1 niiderakita
aizuwakamatsu-shi, fukushima 965-8 520
JA  965-8520
MDR Report Key15846210
MDR Text Key304176576
Report Number2429304-2022-00140
Device Sequence Number1
Product Code FDS
UDI-Device Identifier04953170305290
UDI-Public04953170305290
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 10/27/2022,11/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberGIF-H190
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date10/27/2022
Event Location Hospital
Date Report to Manufacturer10/27/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/22/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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