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 Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pancreatitis (4481)

Event Type  Injury  

Manufacturer Narrative

The specific model number is unknown, gf-uct180 was chosen as a representative device.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.This report was submitted by the importer under the importer's report number 2429304-2023-00340.A copy of the literature is attached.

Event Description

Olympus reviewed the following literature titled "endoscopic ultrasound-guided versus percutaneous drainage for the management of post-operative fluid collections after distal pancreatectomy" methods: adults who underwent distal pancreatectomy from january 2012 to august 2021 and developed symptomatic popfc in the resection bed were retrospectively identified from a single academic center database.Demographic data, procedural data, and clinical outcomes were abstracted.Clinical success was defined as symptomatic improvement andradiographic resolution without requiring an alternate drainage modality.Quantitative variables were compared using a two-tailed t-test and categorical data were compared using chi-squared or fisher¿s exact tests.Results: of 1046 patients that underwent distal pancreatectomy, 217 met study inclusion criteria (median age 60 years, 51.2% female), of whom 106 underwent eusd and 111 ptd.There were no significant differences in baseline pathology and popfc size.Ptd was generally performed earlier after surgery (10 vs.27 days; p < 0.001) and more commonly in the inpatient setting (82.9% vs.49.1%; p < 0.001).Eusd was associated with a significantly higher rate of clinical success (92.5% vs.76.6%; p = 0.001), fewer median number of interventions (2 vs.4; p < 0.001), and lower rate of popfc recurrence (7.6% vs.20.7%; p = 0.007).Aes were similar between eusd (10.4%) and ptd (6.3%, p = 0.28), with approximately one-third of eusd aes due to stent migration.¿type of adverse events/number of patients in eusd group¿ moderate bleeding - 2 patients severe bleeding - 1 patient infection (moderate) - 1 patient pancreatitis (moderate) - 1 patient in patients who died before follow-up, a family member or power of attorney was contacted to gather information regarding the date and cause of death and recorded in the electronic medical record.Four patients in the eusd group (3.6%) died within 6 months of the index procedure from non-procedure related causes, which was assessed as non-reportable.There is no report of any olympus device malfunction in any procedure described in this study.

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 serial and/or 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.Therefore, the root cause cannot be determined.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): 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: 18035498
• MDR Text Key: 326915112
• Report Number: 3002808148-2023-11999
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170356339
• UDI-Public: 04953170356339
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Literature,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2023
• 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: 11/06/2023
• 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
• Patient Outcome(s): Other