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

Model Number	BF-XP60
Medical Device Problem Codes	Break (1069); Peeled/Delaminated (1454)
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 bronchofiberscope had an air/water leakage issue.The device was returned for evaluation.During the device evaluation, the coating of the image guide pipe was peeling off (1mm to 2mm).The resin part of the image guide coil had also fallen off.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
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.The device was returned to olympus for evaluation and the customer's allegation was confirmed.The device evaluation found a cut on the connecting tube, causing water tightness to be lost.Connecting tube had the coating peeled.(1mm2 or more).Based on the results of the investigation, physical stress was applied to the insertion section during user handling and caused the coating to peel.A definitive root cause cannot be identified.A device history review revealed no issues that could have caused or contributed to the reported issue.Important information ¿ please read before use.3.2 inspection of the endoscope: 5.Inspect the external surface of the entire insertion tube including the bending section and the distal end for dens, bulges, swelling, peeling, scratching, holes, sagging, transformations, bends, adhesion of foreign body, dropout of parts, any protruding objects and other irregularities.In addition, the following non-reportable findings were found during the device evaluation: due to a dent on the bending tube, the play of the right/left knob was out of the standard value; due to damage on the channel tube, forceps could not be inserted smoothly; due to damage on the channel tube, channel cleaning brush could not be inserted smoothly; part of the connecting tube had fallen off; eyepiece had a scratch; control unit had a scratch; suction cover had a scratch; grip had a scratch; up and down plate had a scratch; angulation lever had a scratch; light guide connector had a scratch.Olympus will continue to monitor the field performance of 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 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18378897
• Report Number: 9610595-2023-20145
• Device Sequence Number: 7797644
• Product Code: EOQ
• UDI-Device Identifier: 04953170339240
• UDI-Public: 04953170339240
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/21/2023

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-XP60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2023
• Initial Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2009
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown