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U.S. Department of Health and Human Services

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

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AIZU OLYMPUS CO., LTD. GASTROINTESTINAL VIDEOSCOPE Back to Search Results
Model Number GIF-XZ1200
Device Problem Insufficient Information (3190)
Patient Problem Drug Resistant Bacterial Infection (4553)
Event Type  Injury  
Manufacturer Narrative
The device referenced in this report was not returned to olympus for evaluation.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.
 
Event Description
The customer reports there was an outbreak of extended spectrum beta-lactamase-resistant (esbl) bacteria at the hospital in patients who have undergone a procedure with a gastrointestinal videoscope (that had been reprocessed with an automatic scope reprocessor (aer)), per the physician in the infectious diseases department of the facility.The physician requested information regarding endoscope reprocessing methods and culture test methods in order to investigate the cause of the outbreak.It is unknown at this time if the outbreak is related to the scope.The field safety engineer (fse) staff has explained the culture method and reprocessing method to the facility.No scope culture results are available at this time.It is unknown how many patients are involved.It is unknown what treatment/intervention has been provided to the patients.The patients¿ current condition is unknown.This information has been requested and not yet provided.Case with patient identifier (b)(4) reports the scope case with patient identifier (b)(4) reports the automated scope reprocessor the scope has been reprocessed in.
 
Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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 relationship between the subject device and the event could not be identified.There was no detailed information provided by the facility regarding the infected patients.In addition, no details on the user¿s reprocessing methods were confirmed.Therefore, the root cause of this reported event could not be determined.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿if the instruments are not adequately cleaned prior to disinfection/sterilization, these processes will be ineffective.Immediately after each patient procedure and before disinfection/sterilization, thoroughly clean the endoscope and the accessories used with the endoscope.¿ this supplemental report includes a correction to g2.Information added that was inadvertently not included on the initial medwatch.Olympus will continue to monitor field performance for this device.
 
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Brand Name
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 Key15998698
MDR Text Key305683540
Report Number9610595-2022-05602
Device Sequence Number1
Product Code FDS
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/25/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberGIF-XZ1200
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/16/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/17/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
OER-5
Patient Outcome(s) Other;
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