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

Model Number BF-1TQ180

Device Problem Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.A visual inspection was performed on the received device and found the approximately 80% of the bending section cover glue/cement from the distal end broken off.The broken portions of the glue/ cement were not returned for evaluation.The assembly threads were also noted to be broken off.An indentation was observed on the bending section cover glue, however, the glue remained intact on the distal end.The biopsy channel was inspected with an olympus boroscope and was unable to find any foreign objects/materials inside or missing parts.The scope passed the leak test.Based on the investigation results, the damage to the bending section cover glue is due to mishandling.The instruction manual for the bf-1tq180 scope warns users ¿do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector.Also, do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector with excessive force.The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations.It could also cause parts of the endoscope to fall off inside the patient.Olympus followed up with the user facility to obtain additional information regarding the reported event but with no result.

Event Description

Olympus was informed that during a therapeutic bronchoscopy procedure, foreign material from the scope broke off and fell into the patient.The operational coordinator reported that it is believed that the foreign material was the o-ring from the single use biopsy valve; however, the foreign material could not be confirmed.It is unknown if the device fragment was retrieved.It is unknown if the intended procedure was completed.There was no patient injury reported.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information received from the user facility.Olympus received additional information that states that the patient underwent a diagnostic navigational bronchoscopy.The foreign material was retrieved from the patient using forceps.The user facility reported that there was minor bleeding.The intended procedure was completed with the same device.The patient was scheduled for a routine follow up visit with the performing surgeon and then discharged home.Additionally, the foreign material was examined visually and under a magnifying glass post procedure.It was then determined that the foreign material was from the end of the scope at the distal end ring.It was black in color, hard to the touch and of unknown material.The scope, lamp and suction were tested and visually inspected prior to the procedure with no anomalies found.The scope is manually cleaned at bedside, leak tested and then reprocessed in the olympus automatic endoscope reprocessor.

• Brand Name: EVIS EXERA II BRONCHOVIDEOSCOPE
• Type of Device: BRONCHOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 6951579
• MDR Text Key: 90535561
• Report Number: 2951238-2017-00678
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK061313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/06/2017

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-1TQ180
• Device Catalogue Number: BF-1TQ180
• Other Device ID Number: 04953170339349
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Weight: 106