MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA III BRONCHOVIDEOSCOPE

Model Number BF-Q190

Device Problems Break (1069); Fracture (1260); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/18/2017

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has not been returned to olympus medical systems corp.For evaluation.The manufacturing record of the subject device was reviewed with no irregularity.If additional and significant information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that during bronchoscopy, a part of the bending rubber fell off into the patient.The fragment was retrieved and the intended procedure was completed.It was also reported that a part of the bending rubber was peeled at the proximal side.There was no patient injury reported.

Manufacturer Narrative

The device and the fragment have been returned to olympus medical systems corp.For evaluation.During the evaluation, it was confirmed that two parts of resin outside the insertion tube of the subject device were peeled off.Part 1: there were cracks and curling on the resin outside the insertion tube between 100 mm to 145 mm from the distal end of the subject device,.Part 2: there were tears in the axial direction on the resin outside the insertion tube between 200 mm to 210 mm from the distal end of the subject device.It was also confirmed that there were scratches on the fragment.Further, it was confirmed that there were scratches on the distal cover.The exact cause could not be conclusively determined, but the parts of resin outside the insertion tube might be damaged and fell off due to external physical stress.

• Brand Name: EVIS EXERA III BRONCHOVIDEOSCOPE
• Type of Device: BRONCHOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• Manufacturer Contact: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to ; 426425177
• MDR Report Key: 6950659
• MDR Text Key: 90522694
• Report Number: 8010047-2017-01473
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK121959
• 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,Followup
• Report Date: 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BF-Q190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2015
• 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