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

Model Number BF-1TH1100

Device Problems Device Reprocessing Problem (1091); Microbial Contamination of Device (2303)

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

Event Date 10/09/2023

Event Type  malfunction  

Event Description

The customer reported to olympus that during routine microbiological testing, the bronchovideoscope tested positive for 46 colony forming units (cfus)/95ml of microbial growth.All channels were sampled.The user did not report any contamination or any other serious deterioration in state of health of any person, to which the scope could have been a contributory cause.

Manufacturer Narrative

The suspect device has not yet been returned to olympus for evaluation and the investigation is ongoing.The physical device evaluation has not been completed.Prior to the device evaluation, the device was sent out for additional microbiological testing.The cleaning, disinfection, and sterilization (cds) was performed by the customer.The customer confirmed that there were no deviations or deficiencies concerning reprocessing of the scope.Additionally, the customer confirmed that there were no suspected patient infections due to the facility findings.The customer provided the cleaning, disinfection, and sterilization process stating that if precleaning was not performed immediately after the procedure, presoaking was not performed.The device passed the leak test.During manual cleaning, the detergent used was one life.The instrument/suction channel, suction cylinder, and balloon channel were brushed.The forceps elevator was raised and lowered three times when submerged in the detergent solution and flushed.The distal end was brushed with the channel opening brush and single use soft brush, flushed with the distal end flushing adapter, and rinsed before manual disinfection.All channels were flushed with and immersed into the disinfectant.The disinfectant used was enzimed prevent and the channels were flushed with tap water.The concentration and expiration date of the disinfectant was controlled.The automated endoscope reprocessor (aer) used was mini etd 2 with olympus detergent and endodis disinfectant.The customer reported the aer had a water inlet problem with yeast.All channels were connected with tubes when the endoscope was setting up into the aer and the concentration and expiration date of the disinfectant was controlled.The water quality was controlled by filter and the filter was replaced periodically in accordance with the instructions for use.The device was dried by clean towel/paper and filtered compressed air and stored in a drying cabinet.Olympus is the maintenance company.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 supplemental report is being submitted to provide the results of the device evaluation and third party microbiological testing results.The hygiene microbiological investigation report indicated the channels of the scope were cultured and testing detected 1 colony forming unit (cfu)/endoscope of micrococcaceae.The results obtained comply with the target level for an endoscope subjected to high level disinfection and rinsed with sterile water.The device evaluation found foreign material in the channel.In addition to the reportable malfunction, the following were noted: the distal end was scratched; the bending section cover adhesive was separated; the channel mount had signs of wear and tear; the mouth guard piece for endoscopy had a defect; angulation was insufficient.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The reprocessing steps provided by the user were reviewed where the following deviation from instructions for use (ifu) was confirmed: - when manual cleaning was not performed within 1 hour after procedure, pre-soaking was not performed.- brushing for biopsy channel port was not performed at manual cleaning.- displayed ¿water issue, yeast¿ on water supply of the automatic endoscopic reprocessor.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, a deviation from ifu was confirmed therefore, reprocessing may have been conducted insufficiently.Growth of microorganisms were found through culture testing by the user after reprocessing.However, when olympus culture tested after reprocessing in accordance with ifu before repair, the results conformed to the regulation's recommendation.The following is included in the device ifu: "an insufficiently reprocessed endoscope and/or accessory may pose an infection control risk to the patients and/or operators who touch them." 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: 18133807
• MDR Text Key: 328078158
• Report Number: 9610595-2023-17174
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 04953170424199
• UDI-Public: 04953170424199
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K222861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/30/2024

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-1TH1100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/19/2023
• Initial Date FDA Received: 11/14/2023
• Supplement Dates Manufacturer Received: 12/20/2023; 01/29/2024
• Supplement Dates FDA Received: 01/17/2024; 01/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2022
• 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