MAUDE Adverse Event Report: UNKNOWN UNKNOWN - OLYMPUS SINGLE BALLOON ENTEROSCOPE

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Septic Shock (2068); Pancreatitis (4481)

Event Date 09/04/2020

Event Type  Injury  

Event Description

It is reported in the literature titled ¿a comparison of clinical outcomes and cost utility among laparoscopy, enteroscopy, and temporary gastric access assisted ercp in patients with roux en y gastric bypass anatomy,¿ patients experienced adverse events in three study groups using different olympus devices.Case with patient identifier (b)(6) reports the dae group aes (device: olympus single or double balloon duodenoscope-model not specified).Case with patient identifier (b)(6) reports the la-ercp group aes (device: olympus therapeutic duodenoscope-model not specified).Case with patient identifier (b)(6) reports the gate group aes (device: gf-uct180 or tgf-uc180j).Background and aims: gastric access temporary for endoscopy (gate), also known as eus-directed transgastric ercp (edge), has demonstrated advantages over device-assisted enteroscopy (dae) and laparoscopic-assisted ercp (la-ercp) for patients with roux-en-y gastric bypass (rygb) anatomy.We aimed to directly compare clinical outcomes and cost utility among the three ercp modalities method: patients with rygb anatomy who had dae, la-ercp, or gate from 2009 to 2019 at 2 tertiary centers were included in our review.We measured outcomes in three areas: success rate, post-procedural adverse events (aes) and hospitalization, and cost utility per medicare/medicaid insurance payments.Results: s cohort total 130 patients (70 underwent dae, 42 la-ercp, and 18 gate).Success rate dae was successful in 59% of patients, compared to success rates of 98 and 100% for la-ercp and gate, respectively (p <0.001).For dae, 62% of unsuccessful cases required rescue therapy.Adverse events and hospitalization patients who underwent gate had the lowest rate of hospitalization post procedure (44% vs.77% and 100% for dae and la-ercp, respectively, p¿<¿0.01) and spent the least amount of time hospitalized (median time 0 days vs 2 and 3 days for dae and la-ercp, respectively, p<0.0001).Gate had lower ae rates than la-ercp (6 vs 31%, p=0.046), and both had similar rates to dae.Cost utility la-ercp carried the highest total procedural and hospitalization cost per medicare/ medicaid insurance payments (median payment difference of $9.7 k vs gate and $7.9 k vs dae, p<0.01 for both).Procedural and hospitalization costs were similar between gate and dae (p=0.76).Conclusions: gate is a safe modality for ercp with high success rates in rygb patients and exhibits the lowest hospitalization time and rate of adverse events when compared to dae and la-ercp.Gate is similar to dae from a cost utility approach, and both are less costly than la-ercp.Eleven patients in the dae group experienced adverse events (post-ercp pancreatitis [7], septic shock [2], infected hematoma [1], biliary leak [1]) treated with la-ercp, interventional radiology (ir), or repeat dae.There is no report of olympus device malfunction described in this study.

Manufacturer Narrative

The device referenced in this report has not been returned to olympus for evaluation.The investigation is ongoing.The definitive cause of the user¿s experience cannot be determined at this time.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.This event has been reported by the importer on mdr# 2951238 ¿ 2022- 00376.

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 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.Olympus will continue to monitor field performance for this device.

• Brand Name: UNKNOWN - OLYMPUS SINGLE BALLOON ENTEROSCOPE
• Type of Device: UNKNOWN
• Manufacturer (Section D): UNKNOWN; unknown; unknown, unknown UNKNO WN; JA UNKNOWN
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14016919
• MDR Text Key: 293610194
• Report Number: 8010047-2022-05718
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/07/2022
• 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 Number: 1
• Patient Outcome(s): Other; Required Intervention