MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS LUCERA DUODENOVIDEOSCOPE

Model Number JF-260V

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

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001); Pancreatitis (4481); Unspecified Hepatic or Biliary Problem (4493)

Event Date 06/03/2021

Event Type  Injury  

Event Description

Olympus reviewed the following literature "success and safety of needle knife papillotomy and fistulotomy based on papillary anatomy: a prospective controlled trial." literature summary this study aimed to evaluate the validity and safety of this individualized therapy, the initial success rate of biliary cannulation (isrbc), and complication rates of patients who underwent nkp and nkf were compared prospectively among different types of mdps and between two precut approaches.A total of 188 out of 1674 patients undergoing ercp satisfied the criteria for early precutting: 75 patients were assigned to the nkp group and 113 to the nkf group.The total initial success rate of biliary cannulation (isrbc) of the precut techniques (both nkp and nkf) for patients with dbc was 91.5%.The isrbc of patients in the nkp group was similar to that of the nkf group (90.7% vs 92.0%, p>.05).The isrbc of the patients in the swollen mdp subgroup (96.1%) was higher than that of patients in the distorted mdp subgroup (81.8%, p=.030).The total and specific complications of the patients of the nkp group were similar to those of the nkf group (p>.05).This study concluded that nkp and nkf, as selected based on mdp anatomy, are equally safe and highly efficient for patients with dbc to allow biliary cannulation.Selecting a precut method based on mdp anatomy is an efective and safe strategy for patients with dbc.Type of adverse events/number of patients acute pancreatitis (11).Bleeding (4).Cholangitis (1).Perforation (1).Initial unsuccess of biliary cannulation (16).This article includes 2 reports: (b)(6) : jf-260v was selected to represent jf 260 documented in the article.(b)(6) : kd-10q-1 was selected to represent kd-10-1 documented in the article.This report is 1 of 2 for - (b)(6) : jf-260v was selected to represent jf 260 documented in the article.

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.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

Additional information received from the author: the serial number is not available.No malfunctions occurred.The author reported the adverse events were attributed to the patient's underlying pathology and disease state and not the olympus device.

• Brand Name: EVIS LUCERA DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15142131
• MDR Text Key: 297037430
• Report Number: 9610595-2022-00504
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 09/06/2022

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: 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: 07/04/2022
• Initial Date FDA Received: 08/01/2022
• Supplement Dates Manufacturer Received: 08/09/2022
• Supplement Dates FDA Received: 09/06/2022
• 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: KD-10Q-1, LOT UNK; NON-OLYMPUS: GUIDEWIRE, SPHINCTEROTOME, GENERATOR
• Patient Outcome(s): Other; Other; Required Intervention; Required Intervention