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U.S. Department of Health and Human Services

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

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AIZU OLYMPUS CO., LTD. EVIS EXERA III DUODENOVIDEOSCOPE Back to Search Results
Model Number TJF-Q190V
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/05/2023
Event Type  malfunction  
Manufacturer Narrative
The device was not returned to olympus for evaluation.The investigation is ongoing and follow-up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
 
Event Description
The customer reported to olympus the single use distal cover fell off from the evis exera iii duodenovideoscope during withdrawal of the scope at the end of an endoscopic retrograde cholangiopancreatography (ercp).The distal cover was not retrieved, and the patient was reportedly informed by the customer that the distal cover will pass.The ercp was technically difficult due to ampullary stenosis and haraldsson type 4 major papilla, but no maneuvers that could have been disrupting to the cap were done.The distal cap was also checked before use.There were no reports of patient harm.This event is reported under the following patient identifiers: (b)(6) - single use distal cover.(b)(6) - evis exera iii duodenovideoscope.
 
Event Description
The customer confirmed the procedure was therapeutic and it is unknown where in the patient the cap come off.The device came off at the end during withdrawal of the scope.The indication for the procedure was choledocholithiasis, and the patient had no relevant preexisting conditions.
 
Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and fdt additionally, to provide information received through follow up from the customer and an correction to the initial (e1, e2, and e3).The customer confirmed no anti-fog agent was used on the scope lens and boson scientific endoglide water soluble lubrication was applied.After attaching the distal cover to the scope, the user did confirm that the cover was not damaged.The user did attach the distal cover to the scope and then pull or twist the cover to make sure it does not come off.The customer also believes the distal cover was pushed firmly until the hook shown in the attached image of the distal ring were fully visible within the distal cover opening.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is possible that the distal cover did not completely go over hook at the distal end, which is insufficient attachment to the device.It made the cover easy to come off the device.However, the root cause of the phenomenon could not be specified.The event can be detected and prevented by following the instructions for use which state: "detection method is described in 4.1 of chapter 4 in operation manual.Preventive measure is described in 3.5 of chapter 3 in operation manual." olympus will continue to monitor field performance for this device.
 
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Brand Name
EVIS EXERA III DUODENOVIDEOSCOPE
Type of Device
DUODENOVIDEOSCOPE
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 Key16921017
MDR Text Key315115073
Report Number9610595-2023-07412
Device Sequence Number1
Product Code FDT
UDI-Device Identifier04953170405563
UDI-Public04953170405563
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K220587
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup
Report Date 07/19/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberTJF-Q190V
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/12/2023
Initial Date FDA Received05/12/2023
Supplement Dates Manufacturer Received06/19/2023
Supplement Dates FDA Received07/19/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/08/2022
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
BOSON SCIENTIFIC ENDOGLIDE.; MAJ-2315 SINGLE USE DISTAL COVER.
Patient Age33 YR
Patient SexFemale
Patient Weight84 KG
Patient EthnicityNon Hispanic
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