MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE

Model Number BF-UC180F

Device Problem Microbial Contamination of Device (2303)

Patient Problem Unspecified Infection (1930)

Event Date 01/19/2021

Event Type  Injury  

Event Description

The customer contacted olympus to report the subject device was used in two different procedures with two different patients and both patients tested positive for microbes of fusarium oxysporom.The two patients had diagnostic endobronchial ultrasound transbronchial needle aspiration procedures.The physician suspects cross-contamination with the endoscope and the 2 patients.However, the facility tested the endoscope and the results were negative.The 2 patients were treated with antifungals as outpatients.This event includes two complaints as follows: patient identifier (b)(6) is for patient 1.Patient identifier (b)(6) is for patient 2.This report is 2 of 2 for patient identifier (b)(6).

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Manufacturer Narrative

This supplemental report is being submitted for additional information from the customer.Corrected data: b3.New information: b5.

Event Description

The customer provided additional information: the patients samples that obtained fusarium oxysporom complex dna were both obtained on linear endobronchial ultrasound-guided transbronchial needle aspiration from lymph node samples sent for panfungal polymerase chain reaction assay.The procedures were performed at westmead private hospital on (b)(6) 2021 on 2 consecutive cases using the same scope.

Manufacturer Narrative

This supplemental report is being submitted to provide the legal manufacturer's investigation.The dhr for this device were reviewed and all records indicated the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.A definitive root cause was not identified.Based on the available information, the legal manufacturer determined the probable cause of the failure is unable to be determined.The device was not returned for investigation and the customer did not provide the cleaning, disinfection and sterilization procedures either.

• Brand Name: EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE
• Type of Device: ULTRASONIC BRONCHOFIBERVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13253122
• MDR Text Key: 285673807
• Report Number: 8010047-2022-01397
• Device Sequence Number: 1
• Product Code: PSV
• UDI-Device Identifier: 04953170356360
• UDI-Public: 04953170356360
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K070983
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BF-UC180F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2015
• 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