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

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  

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.

• 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
• MDR Report Key: 14164339
• MDR Text Key: 289722401
• Report Number: 2951238-2022-00381
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170343360
• UDI-Public: 04953170343360
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/23/2022,04/20/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: GIF-1TH190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/23/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/23/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/20/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death