MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OES BRONCHOFIBERSCOPE

Model Number	BF-XP60
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was inspected at olympus (b)(4).It was confirmed that the coating of the insertion tube of the subject device was peeled off more than 1mm2 due to the deterioration.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.
Event or Problem Description
Olympus medical systems corp.(omsc) was informed during the incoming inspection for repair at olympus (b)(4), that it was found the coating of the insertion tube of the subject device was peeled off more than 1mm2.The subject device had been returned to olympus china for repair of the of the insertion tube.There was no report of patient injury associated with the event.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information.Olympus medical systems corp.(omsc) reviewed, the manufacturing history (dhr) of the subject device and confirmed, no irregularity.[conclusion]: the root cause of the reported phenomenon could not be identified.[considerations]: based on the following information, omsc presumed, that the cause was physical stress/chemical stress/storage environment.-according to the inspection result of the subject device at olympus china, the coating on the insertion part was peeled off.And there were scratches on the insert part.-ifu states, cautions regarding physical stress, reprocess method and storage environment of device.-according to the former similar case, it had been presumed, that the cause was physical stress/chemical stress/storage environment.If additional information becomes available, this report will be supplemented.

• 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: 12876335
• Report Number: 8010047-2021-15097
• Device Sequence Number: 4509941
• Product Code: EOQ
• UDI-Device Identifier: 04953170308154
• UDI-Public: 04953170308154
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2022

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-XP60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2021
• 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: 10/28/2021
• Supplement Date Received by Manufacturer: 12/15/2021
• Initial Report FDA Received Date: 11/25/2021
• Supplement Report FDA Received Date: 01/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2012
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown