MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEM CORPORATION OLYMPUS EVIS EXERA II BRONCHOVIDEOSCOPE

Model Number BF-Q180

Device Problems Fracture (1260); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/29/2014

Event Type  malfunction  

Event Description

The user facility reported that there was a rough ridge noted approximately 3.5 inches from the distal end, and during a recent bronchoscopy the user experienced difficulty removing the bronchoscope from the tracheostomy tube.Olympus was further informed that after the bronchoscopy, a black rubber piece from the distal end of the bronchoscope was noted in the collected bronchoalveolar lavage (bal) sample.The user facility reported that no device fragment was found inside the patient.There was no patient injury reported.

Manufacturer Narrative

The bronchoscope reference in this report was returned to olympus for evaluation.The evaluation confirmed that the distal end had a rough edge and discoloration on both side of the bending section cover.A portion of the bending section cover was missing, and there were cracks noted.There were excessive dents and scratches noted on the distal end of the bronchoscope.The bronchoscope failed insulation testing due to the damaged distal end cover.In addition, there were scrape marks noted inside the instrument channel 3.5 mm from the distal end.The device was refurbished.The damage found is consistent with physical damage, user techniques, and inaccurate sizing of the endotracheal tube used with the bronchoscope.See scanned page.Also, an olympus endoscopy support specialist (ess) was dispatched to provide the user facility additional training as needed.

• Brand Name: OLYMPUS EVIS EXERA II BRONCHOVIDEOSCOPE
• Type of Device: BRONCHOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEM CORPORATION; 2951 ishikawa-cho, hachioji-shi; tokyo 192- 8507; JA 192-8507
• Manufacturer Contact: noemi schambach ; 2400 ringwood ave.; san jose, CA 95131 ; 4089355002
• MDR Report Key: 4260735
• MDR Text Key: 5029571
• Report Number: 2951238-2014-00505
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023984
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BF-Q180
• Device Catalogue Number: BF-Q180
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/29/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 86 YR
• Patient Weight: 79