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 Problems Bacterial Infection (1735); Unspecified Infection (1930); Sepsis (2067)

Event Date 07/06/2023

Event Type  Injury  

Manufacturer Narrative

Since the literature described "evis exera ii duodenovideoscope", olympus selected "tjf-q180v" as a representative product.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.

Event Description

Olympus reviewed the following literature titled "prevalence and risk factors for multi-drug resistant bacterial infections in patients undergoing endoscopic retrograde cholangiopancreatography".Multi-drug resistant (mdr) bacterial infections represent one of the most challenging public health issues.Some studies highlighted a growing risk of transmission of carbapenem-resistant enterobacteriaceae and other mdr infections in patients undergoing endoscopic retrograde cholangiopancreatography (ercp).Recent evidence reports that a thorough protocol of endoscope reprocessing and screening of patients for mdr might reduce the risk of biofilm accumulation and colonization.However, the risk factors for developing an infection in this setting are poorly characterized.Particularly, patient stratification according to age, comorbidities, type of surgery, and use of prophylactic antibiotic is still uncertain.Starting from these premises, in this single-center study we aimed to evaluate the effectiveness of infection control measures in preventing mdr bacterial infections in patients undergoing ercp.We estimated the prevalence of periprocedural infections occurring after the implementation of an infection surveillance protocol.As a secondary aim, we analyzed the impact of potential risk factors, and we evaluated the adherence of the hospital physicians in implementing the infectious control procedures.Type of adverse events/number of patients: necro-hemorrhagic pancreatitis with positive intra-operative swab for enterobacter cloacae esbl and e.Coli -1 patient, abdominal drainage infection (inserted for fluid collection after cholecystectomy) -1 patient, post-procedure sepsis recovered after empirical antibiotic treatment -1 patient.This literature article requires 3 reports.The related patient identifiers are as follows: (b)(6): tjf-q180v (event 1).(b)(6): tjf-q180v (event 1).(b)(6): tjf-q180v (event 2 and 3).This medwatch report is for patient identifier (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 customer follow-up (b5).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 event cannot be confirmed.There was no complaint reported on the subject device and 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

The customer confirmed that the olympus device did not cause or contribute to any of the patient complications described in the literature.It was also confirmed that the olympus device did not malfunction during any procedure described in the literature.

• 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: 18165668
• MDR Text Key: 328481965
• Report Number: 9610595-2023-17636
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170367311
• UDI-Public: 04953170367311
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 12/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• 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: 12/08/2023
• 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): Hospitalization; Required Intervention