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

Model Number GF-UCT260

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

Patient Problems Abscess (1690); Pulmonary Emphysema (1832); Failure of Implant (1924); Sepsis (2067); Peritonitis (2252); Pancreatitis (4481); Unspecified Gastrointestinal Problem (4491); Unspecified Hepatic or Biliary Problem (4493)

Event Date 11/30/2022

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

Olympus reviewed the following literature titled "a retrospective multicenter study comparing the punctures to b2 and b3 in endoscopic ultrasound¿guided hepaticogastrostomy".Objectives: in recent years,endoscopic ultrasound¿guided hepaticogastrostomy (eus¿hgs) has been performed as an important salvage option for failed endoscopic retrograde cholangiopancreatography for biliary drainage.However, technical issues, such as puncture site (bile duct of segment 3 [b3] or bile duct of segment 2 [b2]), dilation method, stent selection, and procedural safety, need to be resolved for the optimization of eus¿hgs.The present study was to compare the safety, difficulty, and technical and functional success between biliary access via b2 and b3 during eus¿hgs.Methods: we conducted a retrospective investigation of 161 consecutive eus¿hgs cases across a total of 6 facilities, including those at our hospital.The patients were divided into two groups according to the successful drainage route: the puncture to b2 (p-b2) or the puncture to b3 (p-b3).We compared the technical and functional success rates, technical difficulty, and adverse events between the two groups.We also conducted a subgroup analysis to show the factors related to the procedure time.Results: there were 92 cases in the p-b2 group and 69 cases in the p-b3 group.There were no significant differences in the technical success, functional success,or adverse events between the groups;however,the procedure time was significantly shorter in p-b2 cases than in p-b3 cases.The multivariate analysis showed that the puncture site was the only factor related to the procedure time.Conclusions: based on these findings, p-b2 appears useful and safe.P-b2 is as effective as p-b3 and was able to be performed in a shorter period of time.The b2 approach can be considered a useful option for eus¿hgs.Type of adverse events/number of patients: mediastinal emphysema (n=1); sepsis (n=4); ulceration (n=1); bleeding (n=4); peritonitis (n=6); bile leakage (n=4); pancreatitis (n=1); stent slippage (n=3); stent migration (n=1); liver abscess (n=2).This literature article requires 3 reports.The related patient identifiers are as follows: 1.(b)(6) (for gf-uct240-al5); 2.(b)(6) (for gf-uct260); 3.(b)(6) (for single use biliary drainage stent v).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.

• Brand Name: EVIS LUCERA 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 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16341992
• MDR Text Key: 309261646
• Report Number: 3002808148-2023-01242
• Device Sequence Number: 1
• Product Code: ODG
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 02/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GF-UCT260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/11/2023
• 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