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 customer suspected device was returned for investigation.The olympus service center confirmed the reported event during inspection and testing.Upon evaluation of the returned device the following defects were found, due to a pinhole on angle rubber, water tightness lost, due to a pinhole on connecting tube, water tightness lost, connecting tube coating peeling.(1mm2 or more), adhesive on angle rubber chipped, connecting tube wrinkled, due to wear of angle wire, bending angle in up direction did not meet the standard value, adhesive around objective lens peeled, universal cord dented, universal cord scratched, image guide bundle significant breakages, connecting tube dented, and connecting tube buckled.The faulty parts will be replaced, and the device will be returned to the user facility.The subject device was returned to olympus for device evaluation and investigation confirmed the reported issue during investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The investigation noted that it has been more than one year since the device was manufactured.The investigation did not establish a definitive root cause for the reported event.According to the investigation, the event was caused by stress of repeated use, external factors, or handling.Olympus will continue to monitor field performance for this device.
Event or Problem Description
A user facility submitted a repair request to the olympus service center, for a cysto-nephro videoscope, having air/water leaking from the scope angle rubber.Upon inspection and testing of the returned device, coating on the scope image guide snake tube was found peeling.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.There was no report of patient harm or user injury associated with this event.

• 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: 16811529
• Report Number: 9610595-2023-06693
• Device Sequence Number: 2959239
• 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): 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): 04/25/2023

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: 03/27/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 04/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2008
• 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