MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA BRONCHOFIBERVIDEOSCOPE; BRONCHOVIDEOSCOPE

Model Number	BF-XP160F
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the device failed leak test.Damage at the tip of the insertion tubing was observed.The issue was found during reprocessing.There was no patient involvement on this reported issue.No harm was reported.No user injury was reported.Device evaluation found no image.This report is being submitted due to the finding of no image identified during device return evaluation.
Additional Manufacturer Narrative
The subject device was received and evaluated.The reported issue was confirmed.Device evaluation found leaks on a non olympus a-rubber (bending section).Pinholes were observed.Furthermore, as stated in section b5, device evaluation found no image.It was noted that a broken bending section skeleton (non olympus bending section) was found damaged.The no image observed was noted to be likely due to the broken bending section.Following parts of the device were identified to be non olympus: light guide lens, light guide tube, insertion tube (found dent), a-rubber bending section, a-rubber glue, distal end plastic cover.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Updated fields: h6 and h10.The g2 field was corrected based on information available at the time of the initial submission.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 was identified.Based on the results of the investigation, olympus confirmed the bending section cover (a-rubber) was leaking while the user was handling the device causing water invasion.Due to the water invasion, abnormality of electronic parts occurred which led to the malfunction.The suggested event is detectable and preventable by handling the scope in accordance with the following sections of the instructions for use: important information ¿ please read before use precaution for disappeared or frozen endoscopic image; warning ·follow the precautions given below when handling the instrument.Otherwise, the endoscopic image may disappear unexpectedly or the frozen image may not be restored during the examination.Precaution for disappeared or frozen endoscopic image; caution ¿ turn the video system center off before connecting or disconnecting the videoscope cable from the electrical connector on the endoscope.Turn the switch on or off only when the videoscope cable is connected to both the video system center and electrical connector on the endoscope.Failure to do so can result in equipment damage, including destruction of the ccd.¿ do not touch the electrical contacts inside the electrical connector.Ccd damage may result.3.6 inspection of the endoscopic system inspection of the endoscopic image 4.While observing the palm of your hand, confirm that the wli and nbi endoscopic image is free from noise, blur, fog, or other irregularities.5.Angulate the bending section and confirm that the endoscopic image is free from momentary disappearing or other irregularities.Chapter 5 troubleshooting if the endoscope is visibly damaged, does not function as expected or is found to have irregularities during the inspection described in chapter 3, ¿preparation and inspection¿, do not use the endoscope.Contact olympus.Some problems that appear to be malfunctions may be correctable by referring to section 5.1, ¿troubleshooting guide¿.If the problem cannot be resolved by the described remedial action, stop using the endoscope and send it to olympus for repair.Olympus does not repair accessory parts.If an accessory part becomes damaged, contact olympus to purchase a replacement.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA BRONCHOFIBERVIDEOSCOPE
• Common Device Name: BRONCHOVIDEOSCOPE
• 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: 16792735
• Report Number: 9610595-2023-06564
• Device Sequence Number: 12185533
• Product Code: EOQ
• UDI-Device Identifier: 04953170340116
• UDI-Public: 04953170340116
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K033225
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2023

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-XP160F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2023
• Supplement Date Received by Manufacturer: 09/08/2023
• Initial Report FDA Received Date: 04/22/2023
• Supplement Report FDA Received Date: 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2008
• 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