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 02/22/2018

Event Type  malfunction  

Event Description

Tip of rigid bronchoscope broke off during procedure.Surgeon noted this immediately and broken piece recovered from patient's lung.No harm to patient identified.Manufacturer response for bronchoscope, (brand not provided) (per site reporter).No response yet.

• 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: 7326873
• MDR Text Key: 101994766
• Report Number: 7326873
• 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: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/23/2018
• Event Location: Hospital
• Date Report to Manufacturer: 02/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 66 YR