MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. 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
Event or Problem Description
Olympus (omsc) was informed that the customer broncho-fiberscope was returned for service/repair for a reported ¿leak¿ found during an unspecified event.However, upon inspecting and testing, the coating of the insertion tube was found peeling off.The reportable defect was found during service inspection.No death, injury or harm was reported.
Additional Manufacturer Narrative
The customer¿s reported issue was confirmed as the scope was leaking from a hole(s) in the insertion tube.The service evaluation also identified the coating of the insertion tube was found peeling off.Additionally, the bending angulation is below standard specification due to a stretched angle wire.The bending section if loose/wrinkled, the insertion tube is deformed/dented and has scratches, portions of the bending section cover adhesive is missing, the universal cord is deformed/dented with scratches.There are scratches on the control body, eyepiece, grip, angulation lever, up/down plate and the light guide connector.The cause of the peeling insertion tube could not be confirmed.However, the investigation is ongoing; therefore, the root cause of the reported issue cannot be determined at this time.If additional information becomes available a follow up medical device report will be supplemented accordingly.
Additional Manufacturer Narrative
Correction to date rec¿d by mfr of the initial medwatch.The aware date should be 06-mar-2022.This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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 cause the reported event however the root cause could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: OES BRONCHOFIBERSCOPE
• Common Device Name: BRONCHOFIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13997539
• Report Number: 8010047-2022-05623
• Device Sequence Number: 4452770
• 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): 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): 06/22/2022

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: 03/06/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2022
• Supplement Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 04/04/2022
• Supplement Report FDA Received Date: 06/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2016
• 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