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 Apnea (1720); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Hypoxia (1918); Sepsis (2067); Rupture (2208); Peritonitis (2252); Pancreatitis (4481); Unspecified Hepatic or Biliary Problem (4493)

Event Date 05/17/2022

Event Type  Injury  

Event Description

Olympus reviewed the following literature titled "propensity score matching analysis for adverse events of eus-guided biliary drainage in advanced elderly (peace study)." this multicenter, retrospective study was aimed to determine the safety of endoscopic ultrasound-guided biliary drainage (eus-bd) for advanced elderly patients.A total of 271 patients who underwent eus-bd were enrolled in this study (group a=177, group b=94).The types of adverse events that were associated with eus-bd was observed in 38 patients, and they did not differ significantly between two groups.Adverse events were associated with sedation after propensity score matching; hypoxemia and severe hypoxemia were significantly higher in group a compared with group b.This study concluded that eus-bd could be safety performed in advanced elderly patients, the same as in younger patients.Also, capnographic monitoring might be helpful in case of sedation by a gastroenterologist in a non-intubated patient.Type of adverse events/number of patients.Procedure-related adverse events (38) bile peritonitis 24 , bleeding 4, pancreatitis 5, biloma 2, sepsis 2.Procedure-related late adverse events (27) cholangitis 25, hepatic artery rupture 2.Sedation-related adverse events (67), hypoxemia 34, severe hypoxemia 20 , apnea 2, hypotension 11.Death 1.This literature article requires 2 reports.The related patient identifiers are as follows: (b)(6): for the death, (b)(6): for adverse events other than 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 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 provided additional information from the author (see b5).

Event Description

Additional information received from the author: the authoring physician stated: this is a nuanced article stating that respiratory-related complications can be prevented by means of monitoring, and has nothing to do with endoscopic instruments.

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.This supplemental report includes information added to g2.Olympus will continue to monitor field performance for this device.

• 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: 15458770
• MDR Text Key: 300301829
• Report Number: 3002808148-2022-02216
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/01/2022

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: 08/21/2022
• Initial Date FDA Received: 09/20/2022
• Supplement Dates Manufacturer Received: 10/17/2022; 10/12/2022
• Supplement Dates FDA Received: 10/27/2022; 11/01/2022
• 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: NON-OLYMPUS, 0.025-INCH GUIDEWIRE; NON-OLYMPUS, 19 G NEEDLE; NON-OLYMPUS, BALLOON CATHETER; NON-OLYMPUS, ELECTROCAUTERY DILATOR; NON-OLYMPUS, MECHANICAL DILATOR; NON-OLYMPUS, STENTS
• Patient Outcome(s): Required Intervention; Other