MAUDE Adverse Event Report: OLYMPUS CORPORATION OF THE AMERICAS; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 11/29/2017

Event Type  malfunction  

Event Description

Patient was undergoing a flexible bronchoscope, cryoablation, and balloon dilation.Reportedly, during the procedure, a piece of the outer sheath of the bronchoscope came off.Physician was able to recover the piece from the patient.An x-ray was reportedly obtained which confirmed that the piece was removed from the patient.No reported patient harm.

• Type of Device: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): OLYMPUS CORPORATION OF THE AMERICAS; 2400 ringwood ave.; san jose CA 95131
• MDR Report Key: 7178728
• MDR Text Key: 96869610
• Report Number: 7178728
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Other Device ID Number: XTC160
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/06/2017
• Event Location: Hospital
• Date Report to Manufacturer: 12/06/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 74 YR