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U.S. Department of Health and Human Services

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

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AIZU OLYMPUS CO., LTD. EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE Back to Search Results
Model Number GIF-H290T
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Perforation (2001)
Event Date 12/01/2022
Event Type  Injury  
Event Description
Olympus reviewed the following literature titled "treatment strategy for giant 0-is tumors exhibiting muscle layer traction in our hospital".Huge 0-is (stemless) tumors of the large intestine may exhibit high fibrosis and muscle traction, and are considered to be highly difficult cases of esd.In the past, muscle layer traction was one of the guidelines for stopping esd, but it is becoming a lesion that can be overcome by the progress of esd devices including traction devices and various treatment methods such as the tunnel method and pocket-creation method reported by yamamoto, hayashi et al.In our hospital, the tunnel method is the basic strategy for huge 0-is type tumors, and the double tunnel method (dt method) is used for cases with severe fibrosis and muscle layer traction in the center, and the outline of the method is explained.Type of adverse events/number of patients, intraoperative perforation - 1 patient, delayed perforation - 1 patient.This literature article requires 10 reports.The related patient identifiers are as follows: 1.(b)(6): (b)(4) for a patient in case#2, with intraoperative perforation, 2.(b)(6): (b)(4) for a patient in case, #2 with intraoperative perforation, 3.(b)(6): (b)(4) for a patient in case#2 with intraoperative perforation, 4.(b)(6): (b)(4) for a patient in case#2 with intraoperative perforation, 5.(b)(6): (b)(4) for an unknown patient with delayed perforation, 6.(b)(6): (b)(4) for an unknown patient with delayed perforation, 7.(b)(6): (b)(4) for an unknown patient with delayed perforation, 8.(b)(6): (b)(4) for an unknown patient with delayed perforation, 9.(b)(6): (b)(4) for an unknown patient with delayed perforation, 10.(b)(6): (b)(4) for an unknown patient with delayed perforation.This medwatch report is for patient identifier (b)(6).There is no report of any olympus device malfunction in any procedure described in this study.
 
Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation.The investigation is in process.The literature article is attached for additional information.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
 
Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial and/or lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the relationship between the device and the adverse event cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Therefore, the root cause cannot be determined.Olympus will continue to monitor field performance for this device.
 
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Brand Name
EVIS LUCERA ELITE 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 Key16440147
MDR Text Key310232702
Report Number9610595-2023-03259
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,Study,Literature,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/07/2023
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? No
Device Operator Health Professional
Device Model NumberGIF-H290T
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/26/2023
Initial Date FDA Received02/24/2023
Supplement Dates Manufacturer Received03/28/2023
Supplement Dates FDA Received04/07/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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;
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