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
Additional Manufacturer Narrative
The suspect device has been returned to olympus for evaluation and the investigation is in process.The olympus service center found the connecting tube coating peeling off 10-20 centimeters from the distal end.A definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.
Event or Problem Description
A user facility reported to olympus the oes bronchofiberscope was leaking at the bending section after a procedure.User confirmed there was no harm or user injury due to the event.Upon inspection and testing of the customer returned device, it was observed that the connecting tube coating was peeling off.This report is being submitted for the malfunction found during evaluation.
Additional Manufacturer Narrative
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 legal manufacturer's investigation, the cause that led to connecting tube coating peeling off was surmised as follows: 1) improper reprocessing by customer.2) non-olympus approved chemicals used during reprocessing by customer.Specific probable causes may be the following: a.Physical stress: 1.) insertion section was contacted and rubbed by mouthpiece; 2.) the subject device was used for procedure while the insertion section was not smoothly passed through endotracheal tube; b.Chemical stress: 1.) water-insoluble anesthetic spray for pharyngeal area, such as xylocaine spray, was directly sprayed to the insertion section; 2.) the subject device was reprocessed with disinfectant which is not olympus recommendation.The instruction manual identifies the following related verbiage which may help prevent the phenomenon: ¿inspection of the endoscope : inspect the external surface of the entire insertion section, including the bending section and the distal end for dents, bulges, swelling, scratches, peeling of coating, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, protruding objects, or other irregularities.¿ additionally, the user can reduce and reduce/prevent occurrence of the suggested event by handling device in accordance with the following ifu statement and item: ¿operation: insertion or withdrawal with excessive force, or forcible insertion or withdrawal; operation: insertion of the endoscope: if necessary, apply a medical-grade, water-soluble lubricant to the insertion tube; compatible reprocessing methods and chemical agents : olympus endoscopic equipment is compatible with several methods of reprocessing.Certain components and accessories, however, are not compatible with some methods, which can cause equipment damage.For appropriate reprocessing methods, refer to table 2.1 below, the recommendations of your infection control committee and all national and local hospital guidelines and policies.¿ 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: 13226230
• Report Number: 8010047-2022-01231
• Device Sequence Number: 4064657
• Product Code: EOQ
• UDI-Device Identifier: 04953170339264
• UDI-Public: 04953170339264
• Combination Product (Y/N): N
• Initial Reporter Country: LH
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2022

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: 12/19/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2021
• Supplement Date Received by Manufacturer: 02/02/2022
• Initial Report FDA Received Date: 01/11/2022
• Supplement Report FDA Received Date: 02/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2014
• 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