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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS LUCERA ELITE DUODENOVIDEOSCOPE

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AIZU OLYMPUS CO., LTD. EVIS LUCERA ELITE DUODENOVIDEOSCOPE Back to Search Results
Model Number TJF-Q290V
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/01/2023
Event Type  Injury  
Event Description
The customer reported to olympus the evis lucera elite duodenovideoscope cover came off during a diagnostic endoscopic retrograde cholangiopancreatography.After the scope was removed from the patient, the physician noticed that the cover was missing.The doctor retrieved the cover from the duodenal bulb with another scope and grasping forceps and no additional procedures were necessary.It was stated that no mucosal damage occurred.There were no reports of patient harm.Patient identifier (b)(6) is for the evis lucera elite duodenovideoscope.Patient identifier (b)(6) is for the single use distal cover.
 
Manufacturer Narrative
The device was not returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
 
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 less than 1 year since the subject device was manufactured.Based on the results of the investigation, the root cause of the reported event could not be determined.However, the distal cover likely fell off the scope due to the following: 1.Antifogging agent adhered to the cover, which led to breakage due to chemical attack.As a result, the cover came to be easily detached from the endoscope.2.The cover was insufficiently attached to the endoscope, which caused the cover to easily be detached from the endoscope.3.The cover was pushed at an angle when attached to the endoscope, which led to breakage of the cover.As a result, the cover came to be easily detached from the endoscope.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿chapter 3 preparation and inspection, section 3.5 attaching accessories to the endoscope as below: [attaching the single use distal cover] 1 confirm that the instrument channel outlet of the distal end is opened.2 if the instrument channel outlet is not opened, move the elevator control lever in the opposite direction of the ¿u¿ direction until the forceps elevator stops to make the instrument channel outlet opened.3 gently hold the distal part of the bending section and the single use distal cover.Align the opening side of the single use distal cover with the lenses side of the distal end.4 put your finger onto the center on the top of the single use distal cover and push the top of the single use distal cover straight onto the distal end of the endoscope until the hook of the distal ring is completely visible within the opening of the single use distal cover.5 hold the distal part of the bending section.Pull the single use distal cover gently to confirm that the single use distal cover on the distal end of the endoscope does not slip and come off.6 twist the single use distal cover gently in both directions and confirm that the single use distal cover on the distal end of the endoscope does not slip and come off.7 confirm that the single use distal cover is free of cracks or deformation.8 confirm that there is no adhesion of foreign materials between the distal end of the endoscope and the single use distal cover.¿ olympus will continue to monitor field performance for this device.
 
Event Description
Additional information was reported, and indicated that there was a 5 minute procedural delay due to the device issues previously reported.It was unknown if there were any adverse health effects due to the delay.Additional information regarding the outcome was requested but was unknown by the reporter and unable to be provided.
 
Manufacturer Narrative
This supplemental report is being submitted to provide additional information obtained from the customer regarding the reported event.
 
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Brand Name
EVIS LUCERA ELITE 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 Key17019148
MDR Text Key316122052
Report Number9610595-2023-08153
Device Sequence Number1
Product Code FDT
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 06/28/2023
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 NumberTJF-Q290V
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/02/2023
Initial Date FDA Received05/30/2023
Supplement Dates Manufacturer Received06/07/2023
06/26/2023
Supplement Dates FDA Received06/13/2023
06/28/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/27/2022
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
EVIS LUCERA ELITE DUODENOVIDEOSCOPE - LOT H2921.
Patient Outcome(s) Required Intervention;
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