MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

Model Number GF-UCT180

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

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Tissue Injury (4559)

Event Date 01/28/2021

Event Type  Injury  

Event Description

Olympus medical systems corp.(omsc) received a literature titled "eus-guided gallbladder drainage in high-risk surgical patients with acute cholecystitis¿procedure outcomes and evaluation of mortality predictors" literature summary: this retrospective study described the eus-guided gallbladder drainage in high-risk surgical patients with acute cholecystitis (ac) procedure outcomes and evaluation of mortality predictors.Thirty-four patients underwent eus for suspected ac and 25 (44% male, age (b)(6)) were finally included.A curvilinear-array (gf-uct-180) or a forward-view (tgf-uc180j) echoendoscope with a dedicated ultrasound processor (eu-me2) were used.Electrocautery-enhanced lams delivery system (hot-axios, boston scientific) was used in conjunction with the erbe vio 300d electrosurgical unit using pure cut mode (autocut mode, effect 5, power 100 w).Procedures were done under eus guidance without fluoroscopic assistance.Technical, clinical success rate and adverse events rate were 92%, 88%, and 16%, respectively.30-day and 1-year mortality were 12% and 32%.On univariate analysis, age-adjusted charlson comorbidity index (cci) (or 20.8[4¿68.2]), acute kidney injury (aki) (or 21.4[2.6¿52.1]) and clinical success (or 8.9[1.2¿11.6]) were related to 30-day mortality.This study concludes that severe comorbidities and aki were independent predictive factors confirming of long-term mortality after eus-gbd.Outcomes of eus-gbd appear more influenced by patients¿ conditions rather than by procedure success.Since the literature described "gf-uct180/tgf-uc180j", we selected "gf-uct180" as a representative product.This mdr is being submitted to account for the following reported adverse events: bleeding (2), stent obstruction due to tissue overgrowth (1), stroke (1), recurrence of ac with cholangitis and sepsis (1).

Manufacturer Narrative

No device returned to olympus for evaluation.The exact cause of the patients¿ outcome cannot be conclusively determined.If new and relevant information is received later, this report will be updated accordingly.Based on the literature, there was no reported device malfunction; therefore, this report is being submitted in an abundance of caution.

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: EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE
• Type of Device: ULTRASOUND GASTROVIDEOSCOPE
• 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 Key: 14493196
• MDR Text Key: 292571904
• Report Number: 8010047-2022-08822
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170356346
• UDI-Public: 04953170356346
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K093395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GF-UCT180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: No
• 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