MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS LUCERA DUODENOVIDEOSCOPE

Model Number JF-260V

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

Patient Problem Unspecified Infection (1930)

Event Date 04/28/2022

Event Type  Injury  

Event Description

It is reported in the literature titled "increased risk of biliary infection after biliary stent placement in users of proton pump inhibitors" patient's experienced adverse events after endoscopic retrograde cholangiopancreatography (ercp) procedures using and evis lucera duodenovideoscope.Objectives: proton pump inhibitors (ppis) are widely prescribed medications for gastric acid-induced diseases.Despite the effectiveness of ppis, recent evidence suggested an increased risk of various bacterial infections in ppi users.The current study was conducted to evaluate the risk of biliary infection after endoscopic biliary stent placement in regular users of ppis.Methods: consecutive patients with a native papilla who underwent endoscopic retrograde cholangiopancreatography and stent placement for biliary stricture between january 2010 and august 2019 were included in this retrospective study.The cumulative incidences of biliary infection were compared between regular and non-regular ppi users.Results: during the study period, 270 regular ppi users and 146 non-regular ppi users were included in the analyses.Age, gender, and indication of endoscopic retrograde cholangiopancreatography were not different between the two groups.The incidences of biliary infection were 43% in regular ppi users and 36% in non-regular ppi users but the time to biliary infection was significantly shorter in regular ppi users than in non-regular users (28 vs.87 days, p = 0.01).The cumulative incidence of biliary infection was significantly higher in regular ppi users compared with non-regular users (p = 0.008).The multivariable cox regression analysis also showed a significantly higher hazard ratio of biliary infection in regular ppi users (1.62 [95% confidence interval 1.16¿2.26; p = 0.005]).Conclusions: regular ppi use was associated with a higher risk of biliary infection after endoscopic biliary drainage.Inappropriate ppi use should be avoided.There is no report of olympus device malfunction in any procedure described in this study.

Manufacturer Narrative

Model number: the literature reports "jf-260v or tjf-260v", we selected "jf-260v" as a representative product.This report is being submitted to report the user's experiences and investigation findings.The devices referenced in this report were not returned to olympus for physical evaluation.The device history record (dhr) for the complaint devices could not be reviewed since the serial numbers were not provided.Olympus does not ship any device that does not meet all design and safety specifications.Conclusion: no malfunction of any olympus device was reported in any procedure described in this article.From the information reported, it is presumed that the causes of the reported events are not due to product defects, but the definitive cause could not be established.

Manufacturer Narrative

This report is being updated to provide additional information reported by the author/physician and investigation findings.The devices referenced in this report were not returned to olympus for physical evaluation.The device history record (dhr) for the complaint devices could not be reviewed since the serial numbers were not provided.Olympus does not ship any device that does not meet all design and safety specifications.Conclusion: no malfunction of any olympus device was reported in any procedure described in this article.From the information reported, it is presumed that the causes of the reported events are not due to product defects, but the definitive cause could not be established.

Event Description

Additional information provided by the author/physician: no olympus device malfunctioned in any procedure described in this literature.We are unable to provide the serial numbers for the devices used.No olympus device caused or contributed to any of the adverse events experienced by the patients in this study.

• Brand Name: EVIS LUCERA DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14956073
• MDR Text Key: 295485887
• Report Number: 8010047-2022-11575
• Device Sequence Number: 1
• Product Code: FDT
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/11/2022

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: JF-260V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/09/2022
• Initial Date FDA Received: 07/08/2022
• Supplement Dates Manufacturer Received: 07/14/2022
• Supplement Dates FDA Received: 08/11/2022
• 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
• Patient Outcome(s): Other