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

Model Number BF-1T60

Device Problems Break (1069); Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The subject device in this report has not yet been returned to omsc for evaluation.Omsc reviewed the manufacture history of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available or if the device is returned at a later time, this report will be supplemented.

Event Description

Olympus was informed that when the facility was inserting the subject device into an endotracheal tube (ett) before an procedure, the distal end was damaged and a part of the distal end was missing.The procedure was completed using another device.The user facility also reported that absolutely no part of the distal end has fallen off into the patient because the damage occured before the procedure.There was no patient injury associated with this report.

• 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: 7424529
• MDR Text Key: 105403069
• Report Number: 8010047-2018-00640
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: PK023984
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: BF-1T60
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1