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

Model Number	BF-1T60
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 customer returned the device to olympus for evaluation and the customer¿s allegation of image lighting issues were not confirmed.It was discovered however, that the connecting tube had the coating peeling.Additionally, the following events are as follows: (a.) due to deformation of the venting connector of the light guide connector, air cannot be supplied inside the scope, (b.) the bending section cover or distal end had slack, (c.) the adhesive on the bending section cover has a chip, (d.) the connecting tube has a wrinkle, (e.) due to wear of angle wire, bending angle in up direction does not meet the standard value, (f.) due to wear of angle wire, the play of angulation lever is out of the standard value, (g.) the light guide connector has a scratch, (h.) the angulation lever has a scratch, (i.) the up/down plate has a scratch, (j.) the grip has a scratch, (k.) due to damage on image guide bundle, the image has a stain, (k.) the control unit has a scratch, (l.) and the eyepiece has a scratch.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, it is likely that stress of repeated use, external factors, or handling caused the issue.A definitive root cause cannot be identified.This information is addressed in the instructions for use (ifu): "3.Visually inspect the rubber part around the instrument channel port.Figure 3.3 depicts the rubber part in a normal and abnormal condition.Lifting of the rubber part is abnormal.If the rubber part is lifted from the molding part as shown in figure 3.3, (abnormal condition) do not use the endoscope and return it to olympus for repair.4.Inspect the boot and the insertion tube near the boot for bends, twists or other irregularities.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.6.Holding the insertion tube gently with a hard, carefully run your fingertips over the entire length of the insertion tube in both directions.Inspect for any protruding objects or other irregularities.Also confirm that the insertion tube is not abnormally stiff (see figure 3.4)." olympus will continue to monitor the field performance of this device.
Event or Problem Description
The customer reported to olympus the oes bronchofiberscope light does not turn on, or switch off.It is unknown when the events took place.Subsequently during inspection from the olympus staff, it was discovered the coat on the image guide snake pipe is peeling off.This medwatch report is being submitted to capture this reportable malfunction which was identified during the evaluation.

• 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 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17155487
• Report Number: 9610595-2023-09022
• Device Sequence Number: 6021131
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/19/2023

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: 05/22/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2023
• Initial Report FDA Received Date: 06/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2013
• 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