MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. OES BRONCHOFIBERSCOPE

Model Number	BF-1T60
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus, the oes bronchofiberscope had leakage at the tip.Inspection and testing of the returned device found the forceps plug mouthpiece was scraped.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the customer's allegation was confirmed.The device evaluation found watertightness was not maintained due to holes in the curved rubber, the bending angle was insufficient, spots were found on the image guide bundle, poor insulation was found at the tip, the curved rubber adhesive was missing, the forceps plug cap had been scraped off, the operation part was scratched, the eyepiece was scratched, the coating on the grip was lifted, the grip was scratched, the angle lever was scratched, the up/down plate was scratched, the universal cord was scratched, the universal cord was wrinkled, the scope connector side of the universal cord was scratched, and the light guide connector was scratched.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The issue was found during reprocessing following a diagnostic sputum aspiration test.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information based on the information supplied by the customer.Please refer to the following sections for the new information: b5 - event description.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on 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.It has been over 13 years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be established.The suggested phenomenon was presumed to have been due to the stress of repeated use, external factors, or handling.Olympus will continue to monitor field performance for this device.

• Brand Name: OES BRONCHOFIBERSCOPE
• Common Device Name: BRONCHOFIBERSCOPE
• 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: 16061217
• Report Number: 9610595-2022-06189
• Device Sequence Number: 6733647
• Product Code: EOQ
• UDI-Device Identifier: 04953170339264
• UDI-Public: 04953170339264
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/16/2023

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2022
• Supplement Date Received by Manufacturer: 01/23/2023; 01/30/2023
• Initial Report FDA Received Date: 12/28/2022
• Supplement Report FDA Received Date: 01/24/2023; 02/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2009
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-3287-2018
• Patient Sequence Number: 1
• Patient Sex: Unknown