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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

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OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE Back to Search Results
Model Number GIF-1TH190
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Insufficient Information (4580)
Event Date 01/21/2022
Event Type  Death  
Manufacturer Narrative
This report is being submitted report adverse events and to provide investigation results no physical evaluation/inspection could be conducted on the suspect device as it was not returned to olympus.The device history record (dhr) for the complaint device could not be reviewed since the serial number was not provided.Olympus does not ship any device that does not meet all design and safety specifications.There was no report of olympus device malfunction and no information connecting the cause of the reported events to the device.For these reasons, the definitive cause of the reported events could not be determined.This event has been reported by the importer on mdr# 2951238-2022-00381.
 
Event Description
It is reported in the literature titled: ¿endoscopic ultrasound guided gastroenterostomy versus open surgical gastrojejunostomy: clinical outcomes and cost effectiveness analysis,¿ patients experienced adverse events during and after endoscopic ultrasound guided gastroenterostomy (eus-ge) procedures using olympus gastroscopes.Case with patient identifier (b)(6) reports eus-ge group (gif-1th190) aes; case with patient identifier (b)(6) reports eus-ge (gif-1th190) 30-day mortality; case with patient identifier (b)(6) reports eus-ge (gf-uct180) aes; case with patient identifier (b)(6) reports eus-ge (gf-uct180) 30-day mortality.Study background/aim: early data suggests that endoscopic ultrasound-guided gastroenterostomy (eus-ge) is a safe and efficacious option for gastric outlet obstruction (goo).However, there is a scarcity of data comparing outcomes with open gastrojejunostomy (ogj).Method: single-center retrospective cohort study of adult patients hospitalized with goo who underwent eus-ge or ogj between january 1, 2014, and february 28, 2020.Primary outcomes were technical and clinical success.Results: sixty-six patients were included of which 40 (60.0%) underwent eus-ge and 26 (40.0%) underwent ogj.Baseline characteristics were similar with respect to age (70.5 vs 69.7, p=0.81), sex (42.5% vs 42.3% female, p=0.99), median length of follow-up (98.0 vs 166.5 days, p=0.8), prior failed intervention for goo (22.5% vs 26.9%, p=0.68), and the presence of altered anatomy (12.5% vs 30.8%, p=0.07) between eus-ge and ogj, respectively.Technical success was achieved in 37 (92.5%) of eus-ge and 26 (100%) of ogj patients (p=0.15).Eus-ge was associated with faster resumption of oral intake (1.3 vs 4.7 days, p<0.001).Conclusion: there were no significant differences in technical or clinical success, symptom recurrence, reintervention, 30-day readmission, or 30-day mortality between eus-ge and ogj.Eus-ge patients experienced shorter delays to resumption of oral intake and chemotherapy, had shorter lengths of stay, and reduced hospital costs.Further prospective comparative studies are warranted to verify our results.This retrospective cohort study is the largest study to date and demonstrates comparable high technical and clinical success rates between eus-ge and ogj, similar to a prior comparative study.Rates of symptom recurrence, reintervention, and 30-day readmission were not significantly different between the two groups.Although a nearly four-fold difference in 30-day mortality was seen between ogj (3.8%) and eus-ge (12.5%), this did not reach statistical significance.This lack of significance likely reflects the low overall number of events.Furthermore, a difference in mortality between groups was not anticipated given the largely terminally ill patient population with short life expectancy.There is no report of olympus device malfunction described in this study.
 
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Brand Name
EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
Type of Device
GASTROINTESTINAL VIDEOSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA  192-8507
Manufacturer Contact
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key14164370
MDR Text Key289720755
Report Number8010047-2022-06732
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 Study,Literature,Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 04/20/2022
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-1TH190
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/23/2022
Initial Date FDA Received04/20/2022
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) Death;
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