MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. BRONCHOVIDEOSCOPE

Model Number BF-1TQ170

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/18/2023

Event Type  malfunction  

Event Description

The customer reported to olympus that the bronchovideoscope tested positive for unexpected contamination.The issue was found during a routine culture of the scope.The user did not report any contamination or any other serious deterioration in state of health of any persons to which the scope could have been a contributory cause.

Manufacturer Narrative

The suspect device has been returned to olympus for evaluation and foreign objects were found in the biopsy channel near the distal end side.The additional evaluation findings were as follows: the distal end had a dent, the adhesive on the bending section cover had a crack, the connecting tube had a dent, due to wear of the angle wire, bending angle in the "up/down" direction did not meet standard value, due to a dent in the channel tube, the forceps cannot be inserted smoothly, the connecting tube had a scratch, the control unit had a scratch, the scope cover had a scratch, the grip had a scratch, the grip had a scratch, the "up/down" plate had a scratch, the angulation lever had a scratch, the universal cord had coating peeling, the light guide connector had a scratch, the video cable had a scratch, the video connector cable had a scratch, the video connector case had a scratch and the forceps channel port had a dent.Additional information received from the customer shows that the facility tested a patient's bronchoalveolar lavage (bal) fluid on (b)(6) 2023 for mycobacterium tuberculosis complex and rifampicin resistance and that both were not detected.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Manufacturer Narrative

This report is being supplemented to provide additional information provided by the customer.

Event Description

The scope was positive for trace amounts of mycobacterium tuberculosis complex which was detected in a specimen from the bronchovideoscope washings.

Manufacturer Narrative

Update: h4, h6, h10.This report is being supplemented to provide additional information based on the customer provided cleaning disinfection and sanitization (cds) practices and the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Additional details were received regarding the cleaning disinfection and sterilization practices (cds) of the user facility: pre-cleaning was performed using 3m rapid multi-enzyme detergent and psk opa liquid disinfectant, however, there was a possibility that pre-cleaning was delayed due to equipment transfer.There was no pre-soaking of the device.The endoscope channels were brushed during manual cleaning using an olympus - bw-15b reusable brush.The device was not rinsed before manual disinfection.All channels were flushed with and immersed in the disinfectant.The water quality is not always checked in the final rinse.No automatic endoscope reprocessor (aer) was used - manual cleaning disinfection and sterilization (cds) was performed.Based on the results of the investigation, a root cause of the reported positive culture could not be determined.The reported event was not confirmed as the scope was not microbiologically tested.Additionally, the observed foreign material in the biopsy channel could not be identified and a definitive root cause of the issue could not be determined, however, the issue was likely the result of insufficient device cleaning/reprocessing due to observed channel deformation due to physical stress and facility reprocessing deviations from the ifu recommendations: the device was not soaked when manual cleaning was not performed immediately after procedures.Quality of the final rinse water was not constantly controlled.The device was not rinsed before manual disinfection.The event can be detected/prevented by following the instructions for use sections below: reprocessing manual_ rinse water.Reprocessing manual_ manually cleaning the endoscope and accessories _ remove.Detergent solution from all channels.Reprocessing manual_ presoaking the endoscope.Olympus will continue to monitor field performance for this device.

• Brand Name: BRONCHOVIDEOSCOPE
• Type of Device: BRONCHOVIDEOSCOPE
• 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: 17939322
• MDR Text Key: 325731277
• Report Number: 9610595-2023-15217
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 04953170342943
• UDI-Public: 04953170342943
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K121959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BF-1TQ170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/18/2023
• Initial Date FDA Received: 10/16/2023
• Supplement Dates Manufacturer Received: 10/23/2023; 12/27/2023
• Supplement Dates FDA Received: 10/23/2023; 01/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2022
• 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