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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 Problems Contamination (1120); Fluid/Blood Leak (1250)
Patient Problem Drug Resistant Bacterial Infection (4553)
Event Date 08/23/2022
Event Type  Death  
Manufacturer Narrative
This event is reported by the importer in mw 2429304 - 2023 - 00007.The device referenced in this report was returned to olympus for evaluation.Preliminary findings are reported.The investigation is ongoing.Physical evaluation of the returned device: there is fluid leakage from the biopsy channel/ the image was ok after aeration.The camera switch was misaligned.The up angulation was low.The control knob had play.The cover plastic and scratches with sharp edge.The adhesive rubber was cracked/discolored/sharp.The insertion tube had buckles below the boot.The control body had corrosion.The device was refurbished/restored back to olympus original factory specifications.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
 
Event Description
The customer reports three patients who underwent procedures using one (or both) 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.The customer reports 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.Patient three: the patient underwent an esophagogastroduodenoscopy (egd) with biopsy for the indication of acute hemorrhagic anemia; active gastrointestinal bleeding on two dates , 59 days apart with two different gastroscopes.The infection was diagnosed by blood culture on 2 dates 28 days apart.The patient was treated with cefiderocol.The patient¿s current condition is reported to be deceased.Date and cause of death have been requested and not yet provided.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 (1st scope used).Case with patient identifier (b)(6) reports patient three of three (2nd scope used).
 
Manufacturer Narrative
This supplemental report is being submitted to provide a correction to b3.Information has been added that was inadvertently not included in the previous submissions.
 
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 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.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 Key16161778
MDR Text Key307453501
Report Number9610595-2023-00762
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
Date FDA Received01/13/2023
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
Date Returned to Manufacturer01/16/2023
Was the Report Sent to FDA? No
Date Manufacturer Received05/25/2023
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) Required Intervention; Death; Other;
Patient Age59 YR
Patient SexFemale
Patient Weight57 KG
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