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

Model Number TJF-200

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

Patient Problems Pancreatitis (4481); Unspecified Hepatic or Biliary Problem (4493)

Event Date 11/01/2022

Event Type  Injury  

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The investigation is in process.The literature article https://doi.Org/10.1016/j.Gie.2022.10.038, provided for additional information.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

Olympus medical systems corp.(omsc) received a literature titled "endoscopic ultrasound-guided antegrade stent placement in patients with failed ercp as a modality of preoperative and palliative biliary drainage." literature summary this retrospective review study aims to assess the outcomes of eus-guided antegrade biliary drainage (eus-ag) in patients with failed ercp or inaccessible papilla in both the palliative setting and as a modality of preoperative biliary drainage.A total of 54 patients were included.Most common primary cancer was pancreatic cancer in 42.1% (23/54) patients.Indication was palliative in 34 (62.9%) patients and pbd in 20 (37%) patients.Level of block was distal in 35 (64.8%) and proximal in 19 (35.1%) patients.Technical success of eus-ag was 88.7% (47/53).Clinical success was seen in 95.7% (45/47) patients.No severe adverse events were reported related to the procedure.Out of 20 patients who underwent endoscopic-ultrasound biliary drainage (eus-bd) as a modality of pbd, 19 had a distal cbd stricture, while one had a bismuth type i hilar block.Technical success was achieved in 19 (95%) patients.Eus-ag is safe and "effective" after failed ercp in both preoperative and palliative setting.Type of adverse events/number of patients: event1: severe intrahepatic cholestasis - 2 patients, event2: postprocedure cholecystitis - 1 patient, event3: mild pancreatitis - 1 patient, event4: self-limiting pneumoperitoneum - 2 patients, event5: died of advanced disease within 3 months - 7 patients, event6: expired due to pulmonary thromboembolism - 1 patient event7: leak at the pancreaticojejunostomy site - 1 patient, event8: bleeding in the surgical bed needing re-exploration.Despite controlling the bleeding, the patient subsequently developed multiorgan dysfunction and expired - 1 patient, this literature article requires 2 reports.The related patient identifiers are as follows: (b)(6) reports the device gf-uct180 for events 2, 7, (b)(6) reports the device gf-uct180 for events 6, 8.This medwatch report is for (b)(6).There is no report of any olympus device malfunction in any procedure described in this study.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to the initial with information inadvertently left out.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 events 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.Olympus will continue to monitor field performance for this device.

Event Description

Other relevant patient identifiers as follows: (b)(6) (g-260-2545a).(b)(6) (sme-210p-10060).(b)(6) (tjf-260v).(b)(6) (jf-240).

• Brand Name: EVIS 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: 17242620
• MDR Text Key: 318439382
• Report Number: 9610595-2023-09588
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K954451
• 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: 08/03/2023

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: TJF-200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/05/2023
• Initial Date FDA Received: 06/30/2023
• Supplement Dates Manufacturer Received: 07/07/2023
• Supplement Dates FDA Received: 08/03/2023
• 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