MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. OES BRONCHOFIBERSCOPE; FLEXIBLE FIBREOPTIC BRONCHOSCOPE

Model Number	BF-1T60
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is not returning for evaluation.As noted during the in-service visit by the endoscopy support specialist (ess), instead of using suction and the suction cleaning adapter (maj-222) as indicated in the bf-1t60 reprocessing manual, the customer manually flushes detergent, water and air through the scope with a syringe at both the suction cylinder opening and the biopsy port on the scope prior to high level disinfection in the steris 1e sterilization machine.The ess performed the reprocessing in-service with the facility staff.In service visit includes the cleaning and disinfecting information of scopes.Ess informed both the spd manager and the facility staff of the correct reprocessing steps.Ess provided a reprocessing in-service for the bf-1t60 demonstrating the correct reprocessing steps using the suction cleaning adapter (maj-222) and a suction source as called for in the reprocessing manual.The facility spd manager during training indicated they could get suction in the decontamination area to correct the steps and customer was able to locate the suction cleaning adapter maj-222.Ess summary visit : ess answered questions throughout the in-service and informed customer that a suction source and the maj-222 adapter should be used following the brushing of the scope channels to ensure proper reprocessing is performed prior to high level disinfection, explained the importance of each which was acknowledged by all staff in attendance.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Event or Problem Description
It was reported during a reprocessing in-service visit, the endoscopy support specialist found that the customer does not have a suction source and are not able to follow the reprocessing instruction of the device as indicated in the reprocessing manual.There is no patient infection associated on this reported event.There was no patient harm, no user injury reported due to the event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.On august 8, 2022, the endoscope support specialist (ess) was on-site and performed a reprocessing in-service with the staff that covered the guidelines on reprocessing the olympus scopes per the on-track form and reprocessing manual.The staff also performed a return demonstration to show they understood the process.The customer also understood that the olympus reprocessing manuals are the validated source of instructions.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, the root cause of the reported event is unable to be determined.However, the cause of the event is likely due to user¿s understanding differed from olympus recommendation in device handling and reprocessing steps.The event can be prevented by following the instructions for use (ifu) which state: ifu (reprocessing manual) warns against insufficient reprocessing as follows.¿1.4 precautions: an insufficiently cleaned, disinfected or sterilized endoscope and/or accessories may pose an infection control risk to the patients and/or operators who contact them.¿ ifu (reprocessing manual) mentions suction cleaning adapter (maj-222) and suction pump in ¿3.1 required reprocessing equipment¿.The reprocessing steps using suction cleaning adapter (maj-222) and suction pump are mentioned at ¿3.5 manual cleaning¿.Olympus will continue to monitor field performance for this device.

• Brand Name: OES BRONCHOFIBERSCOPE
• Common Device Name: FLEXIBLE FIBREOPTIC BRONCHOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15359059
• Report Number: 9610595-2022-01547
• Device Sequence Number: 20200497
• Product Code: EOQ
• UDI-Device Identifier: 04953170339264
• UDI-Public: 04953170339264
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K023984
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2022

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
• Operator of Device: Health Professional
• Device Model Number: BF-1T60
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2022
• Supplement Date Received by Manufacturer: 09/22/2022
• Initial Report FDA Received Date: 09/06/2022
• Supplement Report FDA Received Date: 10/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2006
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STERIS 1ESTERILIZATION MACHINE.MAJ-222
• Patient Sex: Unknown