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

Model Number BF-1T180

Device Problem Microbial Contamination of Device (2303)

Patient Problem Unspecified Infection (1930)

Event Date 07/09/2015

Event Type  Injury  

Event Description

Olympus was informed that six patients tested positive for microbacterium fortuitum conceptionese after undergoing a bronchoscopy.All six patients were examined by the same bronchoscope.To date, none of the six patients have developed any symptoms.No treatment was provided at this time.The user facility further reported that the subject device was cultured on-site; however, the results are not yet available.The user facility will provide a copy of the results to olympus as soon as it becomes available.It was further reported that the user facility uses a non-olympus automatic endoscope reprocessor (aer) made by custom ultrasonics.The effective concentration of the disinfectant is tested prior to every use.The account also utilizes a non-olympus single use brush manufactured by (b)(4).The device was reprocessed based on olympus recommended practice as stated in the instruction manual.Additionally, an olympus leak tester (model# mu-1) was used for leak testing.There were no problems noted with the account's aer.No additional information provided.

Manufacturer Narrative

The device referenced in this report was returned to olympus for evaluation.The device was inspected with a boroscope and no signs of foreign material or stains inside the biopsy channel or suction port of the device were found.Additionally, there was no evidence of foreign substance found on the bending section cover, bending section cover glue, insertion tube and distal end of the device.The device passed all leakage tests appropriately.Olympus was unable to determine the root cause of the reported event.There were no abnormalities or foreign material found that would likely cause or contribute to the user's reported event.The device was repaired and returned to the user facility.In addition, an olympus endoscopy support specialist (ess) was dispatched to the account and provided an in-service reprocessing training.The ess reported that the account complies with the recommended olympus reprocessing guidelines as stated in the instruction manual.There were no major deviations noted.However, it was noted that the account was using a non-olympus single use cleaning brush.The ess recommended the account to utilize olympus cleaning brushes.Please reference the following mfr#s: 2951238-2015-00319, 2951238-2015-00320, 2951238-2015-00321, 2951238-2015-00322, 2951238-2015-00323.

• Brand Name: 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 avenue; san jose, CA 95131 ; 4089355002
• MDR Report Key: 4946455
• MDR Text Key: 18891065
• Report Number: 2951238-2015-00318
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061313
• 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
• Report Date: 07/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BF-1T180
• Device Catalogue Number: BF-1T180
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2012
• 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