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

Model Number BF-XP190

Device Problems Break (1069); Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/30/2019

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to omsc for evaluation.Omsc reviewed the manufacturing history (dhr) of this device and confirmed no irregularity.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 Description

Olympus medical systems corp.(omsc) was informed that a black plastic piece came out of the subject device and fell off into the patient's lobes of the lung during an unspecified procedure.The facility reported that the black plastic piece had disappeared off the screen and could not be removed.There was no patient injury reported from the user facility.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device has not been returned to olympus medical systems corp.(omsc) but was returned to olympus australia pty ltd (oas).In the evaluation of oas the following was confirmed; instrument channel is leaking.Light guide lens is leaking.Light guide lens is chipped or cracked.Bending section rubber adhesive is detached, chipped, cracked, and missing.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

• Brand Name: EVIS EXERA III BRONCHOVIDEOSCOPE
• Type of Device: BRONCHOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 8653265
• MDR Text Key: 146908761
• Report Number: 8010047-2019-02058
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• PMA/PMN Number: K121959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BF-XP190
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1