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

Model Number TJF-Q180V

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/05/2023

Event Type  Injury  

Manufacturer Narrative

Follow up is in progress to obtain additional information regarding the event.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Event Description

Olympus medical systems corporation reviewed a literature titled "endoscopic retrograde cholangiopancreatography in patients with choledochal cyst, a tertiary care experience." this analysis was to evaluate the clinical features, laboratory values, radiological findings, endoscopic management, and technical success in patients with choledochal cyst (cc).Type of adverse events/number of patient immediate bleeding after sphincterotomy (3), delayed bleeding (1).Immediate bleeding after sphincterotomy was noted in 3 (3%) patients which was stopped with balloon-tamponade by using standard occlusion balloons and spraying with adrenaline (epinephrine) (1/10000), followed by injection of adrenaline (epinephrine) into the papilla between 10 and 12 o¿clock.One ((b)(4)%) patient was admitted with delayed bleed, he was discharged with a smooth recovery after being monitored for 72hrs.There was no procedure-related mortality in our patients.This report is related to patient identifier (b)(6).

• Brand Name: EVIS EXERA II 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 (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18717449
• MDR Text Key: 335525323
• Report Number: 9610595-2024-03321
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: PK
• PMA/PMN Number: K143153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TJF-Q180V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/14/2024
• 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): Required Intervention; Hospitalization