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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-1TH190
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Drug Resistant Bacterial Infection (4553)
Event Date 10/15/2022
Event Type  Death  
Manufacturer Narrative
The device referenced in this report was not returned to olympus for evaluation (although it is anticipated to be).The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.This event has been reported by the importer on mdr# (b)(4).
 
Event Description
The customer reports three patients who underwent unspecified procedures using one of two different gastroscopes tested positive for a rate 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.
 
Event Description
Update: additional information provided by the customer: the procedure being performed was an esophagogastroduodenoscopy (egd) with clip for the indication of hematochezia.The infection was diagnosed 5 days after the procedure by blood culture.The patient was treated with iv antibiotics (cefiderocol).The patient's current condition is reported as deceased.Date and cause of death were not provided.Additional information has been requested.At this time, no additional information has been provided.
 
Manufacturer Narrative
This report is being updated to report additional information provided by the customer.
 
Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was returned to olympus for inspection, and the following non-reportable defects were observed: insufficient angulation, play on angulation control knob, dented plastic distal end cover, and bending section cover was cracked.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 1 year since the subject device was manufactured.Based on the results of the investigation, a root cause of the reported event could not be determined.The olympus endoscopy support specialist (ess) confirmed that after observing the customer's reprocessing steps of the device, there were no deviations from the instructions for use (ifu).The user also confirmed that after performing culture testing of the device, the results were negative.Therefore, a relationship between the reported patient infection and the subject device could not be identified.This supplemental report includes a correction to d9 to provide information that was inadvertently not included on the initial medwatch.An update has been made to h3.Also, additional information has been added to d8 and h4.Olympus will continue to monitor field performance for this device.
 
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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
Manufacturer (Section G)
AIZU OLYMPUS CO., LTD.
3-1-1 niiderakita
aizuwakamatsu-shi, fukushima
Manufacturer Contact
todd brill
800 west park drive
westborough, MA 01581
5082077661
MDR Report Key15846876
MDR Text Key304169298
Report Number9610595-2022-04445
Device Sequence Number1
Product Code FDS
UDI-Device Identifier04953170343360
UDI-Public04953170343360
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112680
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup,Followup
Report Date 05/25/2023
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-1TH190
Was Device Available for Evaluation? Device Returned to Manufacturer
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/27/2022
Initial Date FDA Received11/22/2022
Supplement Dates Manufacturer Received12/20/2022
05/17/2023
Supplement Dates FDA Received01/19/2023
05/25/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/06/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other; Death;
Patient Age59 YR
Patient SexMale
Patient Weight155 KG
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