MAUDE Adverse Event Report: OLYMPUS OLYMPUS BRONCHOSCOPE EBUS

Device Problems Device Or Device Fragments Location Unknown (2590); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/11/2015

Event Type  malfunction  

Event Description

Patient underwent a flexible bronchoscopy, endobronchial ultrasound with mediastinal lymph node biopsy, and emb navigational bronchoscopy with right upper lobe biopsy.Patient tolerated procedure well, however, at the end of the procedure physician noted the balloon of the endobronchial ultrasound which had been removed before was missing (count incorrect) and a bronchoscopy was performed extensively all the way down to the subsegmental divisions of all airway systems.The physician was unable to locate balloon.

• Brand Name: OLYMPUS BRONCHOSCOPE EBUS
• Type of Device: BRONCHOSCOPE EBUS
• Manufacturer (Section D): OLYMPUS; 3500 corporate pkwy. ; center valley PA 18034
• MDR Report Key: 5380556
• MDR Text Key: 36497545
• Report Number: MW5059403
• Device Sequence Number: 1
• Product Code: FCG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 51