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

Model Number BF-P60

Device Problem Unintended Ejection (1234)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

A user facility reported that the angulation was not working on a bronchofiberscope.It was also reported that the atp swab came off in the bx channel.The issue occurred during reprocessing of the device.There was no patient involvement or injuries reported.No additional information has been obtained.

Manufacturer Narrative

The following fields were updated.This supplemental report is being submitted to provide the results of the manufacturer¿s investigation.A device evaluation, a review of the device history record (dhr), and a reference of the instructions for use (ifu) were conducted during this investigation.During the evaluation of the device, multiple deep kinks were noted as well as some deformation, tearing and scrape marks inside the biopsy channel.The angulation was up at ¿0¿.The image fibers were broken, the insertion tube was a non-olympus part and had scratches.The distal sheath was also noted to be a non-olympus part.Black debris was discovered inside the lens and a sticky substance was on the top of the lens.The review of the dhr did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.Olympus doesn¿t instruct sampling method of bioburden investigation for a scope.As a result of the device evaluation and documentation investigation, olympus has concluded that this event occurred as a result of the breakage of the swab in the biopsy channel when the user was sampling for atp test.Olympus will continue to monitor the field performance of this device.

• Brand Name: OES BRONCHOFIBERSCOPE
• Type of Device: 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: 11141651
• MDR Text Key: 243494828
• Report Number: 8010047-2021-01134
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 04953170339196
• UDI-Public: 04953170339196
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023984
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BF-P60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1