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

Model Number	BF-P60
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device referenced in this report was not returned to olympus for evaluation.During the site visit, the olympus representative recommends the use of the suction cleaning adapter with aspiration during manual cleaning.It was explained to both sterile processing department staff and operating room educator that the scopes not reprocessed per valid recommended steps should be removed from use until all validated steps can be properly completed.All documentation, including a copy of the field service request, was sent to or educator and to the endoscopy account manager via email.This report will be updated when new information becomes available or if the device will be returned for evaluation at a later time.
Event or Problem Description
It was reported that during an in-service it was observed that the user facility did not reprocess the bronchoscope based on the recommended reprocessing protocol, as the user facility did not have a suction cleaning adapter or suction source in their decontamination room to reprocess the bronchoscope.There was no adverse event reported.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information provided by the user facility.The operating educator at the user facility reported that the bronchoscope was not used on patient procedure after it has been reprocessed.There was no adverse event associated with the bronchoscope.The customer has ordered the suction cleaning adapter (maj-222) to resolve the reprocessing issue.There had been no malfunction reported on the bronchoscope.The bronchoscope is still operational but has not been used on patient since the olympus in-service has been conducted.
Additional Manufacturer Narrative
The following field has been updated.This supplemental report is being submitted to provide the results of the investigation.The investigation reviewed the device history record (dhr) and instructions for use (ifu).The device was confirmed to be shipped in accordance with the specifications via the dhr.The ifu (reprocessing manual) contains a detailed procedure of reprocessing and warns of the impact of an incorrect method of reprocessing.The ifu (operation manual) includes the following statement regarding reprocessing: ¿after using this instrument, reprocess and store it according to the instructions given in the endoscope¿s companion reprocessing manual.Using improperly or incompletely reprocessed or stored instruments may cause patient cross-contamination and/or infection.¿ per the ifu and confirmation during the in-service, user handling deviated from the ifu.

• 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
• MDR Report Key: 10616943
• Report Number: 8010047-2020-07094
• Device Sequence Number: 2793024
• Product Code: EOQ
• UDI-Device Identifier: 04953170308123
• UDI-Public: 04953170308123
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K023984
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/02/2020

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-P60
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/18/2020
• Supplement Date Received by Manufacturer: 10/05/2020; 11/19/2020
• Initial Report FDA Received Date: 10/01/2020
• Supplement Report FDA Received Date: 10/14/2020; 12/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1