MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

Model Number GF-UCT180

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

Patient Problem Aspiration/Inhalation (1725)

Event Date 07/20/2022

Event Type  Death  

Event Description

Olympus reviewed the following literature titled "eus-guided gastroenterostomy versus duodenal self-expandable metal stent for malignant gastric outlet obstruction: results from a nationwide multicenter retrospective study (with video)." this multicenter, observational study of d-sems and eus-ge procedures for patients with malignant goo was conducted in 97 patients.There were no statistically significant differences regarding technical (92.8% vs 93.7%) or clinical success (83.5% vs 92.4%) were found.Patients in the eusge group had improved stent patency when compared with those patients in the duodenal self-expandable metal stent (d-sems) group at 3 months (92.23% vs 80.6%; adjusted hazard ratio,.37; p z.033).This study concludes that eus-guided gastroenterostomy (eus-ge) seems to have improved patency outcomes when compared with d-sems placement for palliative treatment of malignant gastric outlet obstruction (goo).Type of adverse events/number of patients: [duodenal self-expandable metallic stent], bleeding - 1 patient, perforation - 3 patients, pancreatitis and/or cholangitis - 4 patients, severe pain - 1 patient, death- 1 patient.[eus-guided gastroenterostomy]: bleeding - 21 patients, perforation - 1 patient, misdeployment - 3 patients, severe pain - 1 patient, death- 1 patient.This literature article requires 8 reports.The related patient identifiers are as follows: (b)(6): gif-1th190 (ae).(b)(6): gif-1th190 (death).(b)(6): gf-uct180 (ae).(b)(6): gf-uct180 (death).(b)(6): pbd-v813w-07 (ae).(b)(6): pbd-v813w-07 (death).(b)(6): b-v232p-a (ae).(b)(6): b-v232p-a (death).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 doi.Org/10.1016/j.Gie.2022.07.018 provided for additional information.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the author and 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 / 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.

Event Description

In the medical opinion of the author, the olympus device did not cause malfunction nor the adverse events reported.One of the authors also provided the serial number for one of the devices used at their facility.

• Brand Name: EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE
• Type of Device: ULTRASOUND GASTROVIDEOSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16024410
• MDR Text Key: 305916037
• Report Number: 3002808148-2022-05461
• Device Sequence Number: 1
• Product Code: ODG
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K093395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• 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?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/25/2023
• 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 Number: 1
• Treatment: NON-OLYMPUS, ELECTROSURGICAL GENERATOR; NON-OLYMPUS, HOT-AXIOS; NON-OLYMPUS, JAGWIRE; NON-OLYMPUS, WALLFLEX DUODENAL; OLYMPUS 4.5F 3-LUMEN BALLOON-V; OLYMPUS 7F NASAL-BILIARY DRAINAGE TUBE-V; OLYMPUS, GIF-1TH190
• Patient Outcome(s): Death