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 Hemorrhage/Bleeding (1888); Peritonitis (2252); Pseudoaneurysm (2605); Pancreatitis (4481); Unspecified Hepatic or Biliary Problem (4493)

Event Type  Injury  

Event Description

Olympus reviewed the following literature titled: endoscopic ultrasound-guided hepaticogastrostomy versus hepaticogastrostomy with antegrade stenting for malignant distal biliary obstruction.Literature summary.Recurrent biliary obstruction (rbo) is a possible complication of endoscopic ultrasound-guided hepaticogastrostomy (eus-hgs) in patients with malignant distal biliary obstruction (mdbo).Methods: we retrospectively evaluated consecutive patients who underwent eus-hgs or hgas.The trbo, overall survival (os), and adverse event (ae) rate were compared between the groups.Results: this study included 96 patients (eus-hgs, n = 58; hgas, n = 38).There was a significant difference in the cause of endoscopic retrograde cholangiopancreatography failure and the hgs stent type between the groups.Conclusions: endoscopic ultrasound-guided hepaticogastrostomy prolonged the trbo compared with eus-hgs for biliary drainage in patients with mdbo.Type of adverse events/number of patients.Recurrent biliary obstruction - 20 patients.Peritonitis - 5 patients.Cholangitis - 2 patients.Pancreatitis - 5 patients.Bleeding - 2 patients.Death 10 days after onset of septic shock - 1 patients.Pseudoaneurysm - 2 patients.Death in the follow up - 97 patients (not reportable).This article includes 6 complaints as follows: (b)(6) :na-u200h-8019s (septic shock/death).(b)(6) :na-u200h-8019s (for adverse events only).(b)(6) :gf-uct260 (septic shock/death).(b)(6) :gf-uct260 (for adverse events only).(b)(6) :jf-260v (septic shock/death).(b)(6) :jf-260v (for adverse events only).This report is 4 of 6 for (b)(6) :gf-uct260 (for adverse events only).

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.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the author and the legal manufacturer's investigation.New information added to the following fields: h6, h10.The device history records (dhr) for this device could not be reviewed since the serial number was not provided.Olympus ships devices manufactured according to all applicable procedures and meet final product release criteria.A definitive root cause was not identified.Based on the available information, the legal manufacturer was unable to determine the probable cause of the adverse events since the device was not returned for evaluation.No malfunctions were reported.Olympus will continue to monitor field performance for this device.

Event Description

The author provided additional information: the olympus serial/lot numbers are unknown.The adverse events and deaths were not cause or contributed by an olympus device.The adverse events and deaths are attributed to an exacerbation of the disease.The device is not available for return.

• 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 Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15294451
• MDR Text Key: 298609881
• Report Number: 3002808148-2022-01383
• 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,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 07/27/2022
• Initial Date FDA Received: 08/25/2022
• Supplement Dates Manufacturer Received: 09/09/2022
• Supplement Dates FDA Received: 10/06/2022
• 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: UNK LOT/SERIAL: NA-U200H-8019S,JF-260V,TJF-260V
• Patient Outcome(s): Other