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

Model Number TJF-Q190V

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

Patient Problem Pancreatitis (4481)

Event Date 03/02/2023

Event Type  Injury  

Manufacturer Narrative

The literature is attached for additional information.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 corp.(omsc) received a literature titled "fluorescence in situ hybridization in primary diagnosis of biliary strictures: a single-center prospective interventional study." background and aims: diagnosis of the biliary stricture remains a challenge.In view of the low sensitivity of brush cytology (bc), fluorescence in situ hybridization (fish) has been reported as a useful adjunctive test in patients with biliary strictures.We aimed to determine performance characteristics of bc and fish individually and in combination (bc + fish) in the primary diagnosis of biliary strictures.Methods: this single-center prospective study was conducted between april 2019 and january 2021.Consecutive patients with unsampled biliary strictures undergoing first endoscopic retrograde cholangiopancreatography in our institution were included.Tissue specimens from two standardized transpapillary brushings from the strictures were examined by routine cytology and fish.Histopathological confirmation after surgery or 12-month follow-up was regarded as the reference standard for final diagnosis.Results: of 109 enrolled patients, six were excluded and one lost from the final analysis.In the remaining 102 patients (60.8% males, mean age 67.4, range 25¿92 years), the proportions of benign and malignant strictures were 28 (27.5%) and 74 (72.5%), respectively.The proportions of proximal and distal strictures were 26 (25.5%) and 76 (74.5%), respectively.In comparison to bc alone, fish increased the sensitivity from 36.1% to 50.7% (p = 0.076) while maintaining similar specificity (p = 0.311).A total of three patients developed mild post-ercp pancreatits (pep).Per literature definition, pep with a short hospitalization were considered as mild complications.There were no lethal or severe complications related to the study methods.Supplementary table s3 shows the demographic parameters of the patients who died during the follow-up.During the study period, 11 (10.8%) patients died.This includes 10 (90.9%) with malignant strictures and one patient who was a 73-year-old male with chronic pancreatitis and a stenosis of the distal bile duct who died after six months of lung cancer.Conclusions: dual-modality tissue evaluation using bc + fish showed an improving trend in sensitivity for the primary diagnosis of biliary strictures when compared with bc alone.Patient identifiers: (b)(6) :tjf-q180v, pep, (b)(6) :tjf-q190v, pep, (b)(6) :bc-v600p-3010, pep, (b)(6) : tjf-q180v, 10 deaths, (b)(6) : tjf-q190v, 10 deaths, (b)(6) : bc-v600p-3010, 10deaths, (b)(6): tjf-q180v, death of the 73 year old, (b)(6) : tjf-q190v, death of the 73 year old, (b)(6) : bc-v600p-3010, death of the 73 year old.This report is for (b)(6).

Event Description

Olympus further received information confirming that the death cases were caused by medical condition and diagnosis that the patients had.It was not caused by the olympus devices in any way.

Manufacturer Narrative

This report is being supplemented to provide additional information from author and additional information based on the legal manufacturer's final investigation.Updated b5 to reflect the additional information received.Investigation could not specify the root cause of the suggested event conclusively.The literature states that ¿there were no lethal or severe complications related to the study methods¿.A malfunction was not reported associated with the event.An investigation did not identify any device problems related to the events.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA III 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: 16679431
• MDR Text Key: 312675624
• Report Number: 9610595-2023-05595
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170405563
• UDI-Public: 04953170405563
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: K220587
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TJF-Q190V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/19/2023
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization