MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEM CORPORATION OES BRONCHOFIBERSCOPE

Model Number BF-10

Device Problems Detachment Of Device Component (1104); Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/03/2015

Event Type  malfunction  

Event Description

Olympus received a voluntary medwatch that stated, "the intensivist was performing a bronchoscopy in the patients room in icu.A mission partner from respiratory therapy and the rn caring for the patient were at the bedside during the procedure with the intensivist.During the procedure the intensivist noticed that there was a foreign body within the lung of the patient.The foreign body was in the shape of a ring, was black in color, and 1mm in size.The intensivist was unable to retrieve the foreign body from the patients lung.The original procedure was aborted and the bronchoscope was removed from the patient.It was noted that a small portion of material at the end of the scope was missing.The intensivist consulted the pulmonologist to perform an additional bronchoscopy to retrieve the foreign body.The pulmonologist was successful in retrieving the foreign body.Upon removal of the foreign body form the patient it was inspected and confirmed that it was form the tip of the bronchoscope." olympus followed up with the user facility to obtain additional information regarding the reported event and was informed that the patient was discharged home.No further information was provided.

Manufacturer Narrative

The device referenced in this report has not yet been returned to olympus for evaluation.The exact cause of the reported event could not be conclusively determined at this time.A review of the instrument history found no service record for the device as olympus no longer manufactures, sell, service or repair this bronchofiberscope since september 2004.If additional information is received at a later time this report will be supplemented.

• Brand Name: OES BRONCHOFIBERSCOPE
• Type of Device: BRONCHOFIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEM CORPORATION; 2951 ishikawa-cho,; hachioji-shi; tokyo 192- 8507; JA 192-8507
• Manufacturer Contact: noemi schambach ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355002
• MDR Report Key: 4893413
• MDR Text Key: 18377495
• Report Number: 2951238-2015-00302
• 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: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BF-10
• Device Catalogue Number: BF-10
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 73