MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEM CORP EVIS EXERA BRONCHOVIDEOSCOPE; BRONCHOSCOPE

Model Number BF-160

Device Problem Device Disinfection Or Sterilization Issue (2909)

Patient Problem Unspecified Infection (1930)

Event Date 11/09/2014

Event Type  Injury  

Event Description

Olympus was informed that fourteen pts tested positive for bacterial micro-organisms after having undergone a diagnostic bronchoscopic procedure.The positive cultures were klebsiella pneumoniae (cre) and pseudomonas aeruginosa (pan s).It was reported that the scope has repeatedly tested positive for cultures after reprocessing.The device was removed from service on (b)(6) 2014.It is also noted that the scope has been repaired by a third-party vendor.Olympus followed up with the user facility and a on-site visit will be scheduled to perform a boroscope on the scope.The user facility has agreed to send the device to an independent laboratory for further testing once this has been completed.No further info has been provided.

Manufacturer Narrative

The device referenced in this report has not yet been returned to olympus for eval.The exact cause of the pt's experience could not be conclusively determined at this time.A supplemental report will be submitted if add'l info and significant info becomes available at a later time.Please cross-reference the following reports for the associated thirteen complaint cases: mfr reports#'s: 2591238-2014-00629, 2591238-2014-0651, 2591238-2014-00652, 2591238-2014-00653, 2591238-2014-00654, 2591238-2014-00655, 2591238-2014-00657, 2591238-2014-00658, 2591238-2014-00659, 2591238-2014-00660, 2591238-2014-00661, 2591238-2014-00663.

Manufacturer Narrative

This supplemental report is being submitted to provide the device evaluation base on an on-site visit on 01/14/2015 by the endoscopy support specialist (ess) at the user facility.During the ess visit the device was visually inspected and it was apparent that the device was repaired by a non-olympus vendor as non-olympus components were identified on the device; insertion tube and channel.Abnormal angulation movement was observed at the bending section of the device.It was also noted that the boot cover on the lg was worn and there was a noticable gap.Also the boot cover appeared too short and a bit jagged.The device was boroscoped using an olympus autoclavable camera head, arthroscope, and angioscope.Visual inspection found that the biopsy channel had non-olympus material on approximately half the length of the insertion tube.Further investigation, found that the biopsy channel showed signs of scrapes in several areas and a dark area (stain/debris) was observed on the channel wall at the air/water section from the distal end to the biopsy port opening.There were stains and debris found near the bottom of the biopsy port from the biopsy cap to the channel.The ess reported that the user facility uses non-olympus cleaning brushes during reprocessing which are shorter than the recommended olympus cleaning brush.The ess educated the user facility and informed them that the use of a third party components on this scope may compromise the device and could result in harboring bacteria if the inside of the device becomes damaged.The user facility was informed that the olympus reprocessing procedures/protocol are only validated for devices that meet olympus specifications.The device is not validated when it serviced/repaired by a third party vendor.The ess was informed that the device will not be returned to olympus for further testing.At this time the user facility did not provide the device for further testing.The user facility currently uses a custom ultrasonics aer, non-olympus accessories and cleaning brushes during their reprocessing of the devices.It was recommended by the ess that the user facility flush the biopsy port the same way as the air/water channel.The user facility procedures includes culturing every device after it is reprocessed to ensure patient safety.

• Brand Name: EVIS EXERA BRONCHOVIDEOSCOPE
• Type of Device: BRONCHOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEM CORP; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: noemi schambach ; 2400 ringwood ave.; san jose, CA 95131 ; 4089355002
• MDR Report Key: 4380510
• MDR Text Key: 17216261
• Report Number: 2951238-2014-00656
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BF-160
• Device Catalogue Number: BF-160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2014
• Initial Date FDA Received: 12/24/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/24/2015
• 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): Other