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 Problems Hemorrhage/Bleeding (1888); Pancreatitis (4481); Unspecified Hepatic or Biliary Problem (4493)

Event Date 01/02/2019

Event Type  Injury  

Manufacturer Narrative

Model number: the literature described jf-260v and tjf-260v, we selected jf-260v as a representative product.The device referenced in this report has not been returned to olympus for evaluation.The investigation is ongoing.The definitive cause of the user¿s experience cannot be determined at this time.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

It is reported in the literature titled ¿risk factor of bleeding after endoscopic sphincterotomy in average risk patients,¿ patients experienced adverse events during or after endoscopic sphincterotomy procedures using evis lucera duodenoscopes requiring endoscopic hemostasis.Study aim: for therapeutic endoscopic retrograde cholangiopancreatography (ercp), endoscopic sphincterotomy (es) is necessary but it can lead to complications such as bleeding.Thus, we investigated the risk factors of post-es bleeding in average risk patients.Method: retrospective review of medical records of patients who had been treated for ercp between april 2006 and march 2013.The length of the es incision was defined as minimal (up to proximal hooding fold), medium (between minimal and full length), and full (up to superior margin of sphincter opening).Exclusion criteria were as follows: if per formed precut sphincterotomy or balloon dilatation, patients having altered anatomy or anticoagulant medications.Results: a total of 3620 patients underwent ercp and 1121 patients who underwent biliary es were enrolled.Post-es bleeding occurred in 108 of 1121 patients (9.6%) and mostly minor bleeding (94 patients, 87%).Length of es was the only risk factor for post-es bleeding in multivariate analysis.Complete hemostasis was achieved by endoscopic modalities and no serious complication developed after hemostasis.Conclusion: in average risk patients, length of es was independent risk factor for post-es bleeding and endoscopic hemostasis was safe and effective.Out of the 108 patients who had post-es bleeding, 88.0% (n=95) had immediate bleeding, while 12.0% (n=13) had delayed bleeding.Additionally, 87.0% (n=94) had mild post-es bleeding, while 13.0% (n=14) had moderate post-es bleeding.There were no events of severe post-es bleeding.Ninety-seven patients required endoscopic hemostasis.All of the 97 patients achieved complete hemostasis following the endoscopic hemostasis procedure, and there were no patients who required angiographic embolization or surgery.Specifically, 50.9% (n=55) of the patients achieved hemostasis solely by electrocautery, and 38.9% (n=42) of the patients required both electrocautery and hypertonic saline injection.The remaining 10.2% (n = 11) of the patients achieved spontaneous hemostasis, and thus did not require endoscopic hemostasis.There is no report of olympus device malfunction described in this study.

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 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.Olympus will continue to monitor field performance for this device.

• 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: 14083607
• MDR Text Key: 294525365
• Report Number: 8010047-2022-06108
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 05/25/2022

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: 03/14/2022
• Initial Date FDA Received: 04/12/2022
• Supplement Dates Manufacturer Received: 04/27/2022
• Supplement Dates FDA Received: 05/26/2022
• 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; Required Intervention