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); Pain (1994); Perforation (2001); Obstruction/Occlusion (2422)

Event Date 10/17/2022

Event Type  Injury  

Event Description

Olympus reviewed the following literature titled, "efficacy and safety of endoscopic drainage of peripancreatic fluid collections: a retrospective multicenter european study" background: endoscopic ultrasound (eus)-guided transmural drainage allows treatment of symptomatic peripancreatic fluid collections (pfcs), with lumen-apposing metal stents (lams) and double pigtail plastic stents (dpps) being the 2 most frequently used modalities.Methods: consecutive patients undergoing pfc drainage in 10 european centers were retrospectively retrieved.Technical success (successful deployment), clinical success (satisfactory drainage), rate and type of early adverse events, drainage duration and complications on stent removal were evaluated.Results: a total of 128 patients¿92 men (71.9%), age 57.2±11.9 years¿underwent drainage, with pancreatic pseudocyst (pc) and walled-off necrosis (won) in 92 (71.9%) and 36 (28.1%) patients, respectively.Lams were used in 80 (62.5%) patients and dpps in 48 (37.5%).Technical success was achieved in 124 (96.9%) of the cases, with no difference regarding either the type of stent (p>0.99) or pfc type (p=0.07).Clinical success was achieved in 119 (93%); pc had a better response than won (91/92 vs.28/36, p<0.001.Conclusions eus-guided drainage of pfcs achieves high percentages of technical and clinical success.Drainage using lams is of shorter duration, but the complication rate is similar between the 2 modalities.Type of adverse events/number of patients.Bleeding - 7 patients.Perforation - 4 patients.Migration - 3 patients.Obstruction/fever - 4 patients.Pain - 1 patient.Other (transient pylorus obstruction) - 1 patient.Stent deployment failure - 4 patients.Complications at removal - 10 patients.This literature article requires 2 reports.The related patient identifiers are as follows: 1.(b)(6) /gf-uct140-al5.2.(b)(6) /gf-uct180.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

Although the literature stated "eu-me2 premier plus, evis eus," the complaint was not initiated because no malfunctions were described in the literature for the eu-me2 endoscopic ultrasound center, and no adverse events were associated with it.The suspect device has not been returned to olympus for evaluation.The investigation is in process.The literature article is attached for additional information.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

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: 16357659
• MDR Text Key: 309366161
• Report Number: 3002808148-2023-01300
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170341809
• UDI-Public: 04953170341809
• Combination Product (y/n): N
• Reporter Country Code: GR
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• 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: 06/28/2023
• 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 DEVICE: FG-36UA OR EG-3870UTK
• Patient Outcome(s): Other