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

Model Number	BF-3C40
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned and evaluated, and the customer¿s allegation (leakage) was confirmed due to a pinhole on the connecting tube, there was water leakage.In addition to the coating peeling (1mm2 or more) on the connecting tube, additional evaluation findings were as follows: the plastic on the bending section cover had a chip, the connecting tube had a wrinkle, the bending angle in the up direction did not meet the standard value, due to a dent on the channel tube, the forceps and channel cleaning brush could not be inserted smoothly, the adhesive around the objective lens had corrosion, the adhesive around the light guide lens had discoloration, the control unit was sticky due to water leakage, the universal cord had a dent, and the indication on the grip and the up/down plate were peeled.Also, the control unit had discoloration, the image had a stain, and the connecting tube had a dent.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.
Event or Problem Description
The customer reported that when using an oes bronchofiberscope there was a leakage.There was no patient harm associated with the event.The device was returned and evaluated, and upon estimation, the connecting tube had coating peeling (1mm2 or more).This mdr is being submitted to capture the reportable malfunction found during the device evaluation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of device history record and historical complaints analysis was conducted and no deviations that could have caused or contributed to the reported issue were identified.It has been over 8 years since the subject device was manufactured.Based on the results of the investigation, it is likely the coating on the insertion tube peeled off due to stress of repeated use, external factors, or handling.However, a definitive root cause could not be determined.The following information is stated in the instructions for use (ifu): ¿3.2 preparation and inspection of the endoscope: 5.Inspect the external surface of the entire insertion tube including the bending section and the distal end for dents, bulges, swelling, peeling, scratching, holes, sagging, transformation, bends, adhesion of foreign body, dropout of parts, any protruding objects or other irregularities.¿ 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: 17642239
• Report Number: 9610595-2023-12377
• Device Sequence Number: 7936676
• Product Code: EOQ
• UDI-Device Identifier: 04953170339219
• UDI-Public: 04953170339219
• 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
• Report Date (Section B): 08/29/2023

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-3C40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2023
• Supplement Date Received by Manufacturer: 08/28/2023
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2015
• 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
• Patient Sex: Unknown