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

Model Number BF-1T180

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Date 01/01/2014

Event Type  Injury  

Event Description

The user facility reported that a total of 22 patients had tested positive for e.Coli and pseudomonas aeruginosa, and candida after undergoing a bronchoscopy procedure from (b)(6) 2014.All the patients were reported to have been examined using the same device but by different physicians.The user facility conducted two sets of culture test on the o-ring of the device using their in-house laboratory and an independent laboratory.Both culture tests were positive for micro-organisms.Many of the patients that tested positive for the aforementioned micro-organisms had pre-existing respiratory problems.The treatment provided to the patients varied but many received iv antibiotics.All patients have fully recovered and have been cleared of the suspected infections.The user facility has removed the device from use as of (b)(6) 2014.

Manufacturer Narrative

The device referenced in this report has not yet been returned to olympus for evaluation.The exact cause of the patient's outcome could not be conclusively determined at this time.However, review of the instrument history showed that the device was purchased on (b)(6) 2013, but the device has not been returned to olympus for service since then.If additional information becomes available at a later time, this report will be supplemental.Please reference the associates devices, see mfr reports: 2951238-2014-400, 401,402, 403, 404, 405, 406, 407, 408, 409, 410, 411, 412, 413, 414, 415, 416, 418, 419, 420, 421.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information regarding the in-service visits provided by the endoscopy support specialist (ess) on august 21, 2014 and october 3, 2014.The ess visited the user facility to observe the user facility's reprocessing practices.During the in-service visit it was observed that the endoscopes were being hung with peel pack covers (distal tip protectors) over the insertion tubes while drying.As part of educating the customer, a copy of the distal tip protector letter from infection control was provided to the user facility as well as both manuals on the proper cleaning and reprocessing of the 180 series bronchoscopes and colonoscopes.It was also reported that no other reprocessing deviations were found during the on-site visit.Olympus does not recommend nor endorse the use of the distal tip protectors during storage.It was noted that the endoscope distal tip protectors are not to be reprocessed or reused.Reuse could present an infection control risk if the distal end protectors cannot be thoroughly dried.Additionally, the attachment of a non-sterile distal tip protector to the endoscope which has been high-level disinfected or sterilized may cause recontamination of the endoscope.Olympus bronchoscope instruction manual advises users: "storage of endoscope: to hang the endoscope in the storage cabinet with the distal end hanging freely." if additional or significant information is available at a later time, this report will be supplemented accordingly.

• Brand Name: EVIS EXERA II 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 (Section G): OLYMPUS MEDICAL SYSTEM CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: noemi schabach ; 2400 ringwood ave.; san jose, CA 95131-1700 ; 4079355002
• MDR Report Key: 4101724
• MDR Text Key: 21493312
• Report Number: 2951238-2014-00417
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BF-1T180
• Device Catalogue Number: BF-1T180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/08/2014
• Initial Date FDA Received: 08/28/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/25/2015
• 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