MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION EVIS EXERA II BRONCHOVIDEOSCOPE; OLYMPUS BF TYPE 1T180

Model Number BF-1T180

Device Problem Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problem Unspecified Infection (1930)

Event Date 12/11/2014

Event Type  Injury  

Event Description

Olympus medical systems corp (omsc) was informed that the secretions of four patients tested positive for multidrug-resistant acinetobacter after having undergone a bronchoscopy procedure.It was performed for the subject device that manual pre-cleaning, leakage test and reprocessing by aer with validated procedure.The subject device and the aer were tested negative for contamination by an external specialized laboratory for micro-organisms.Leakage test and visual inspection were performed by the facility with no irregularity.The four patients needed to be treated, but they did not need to be hospitalized or prolonged.

Manufacturer Narrative

The device referenced in this report has been returned to olympus europa (b)(4) for eval.Based upon the eval, biopsy channel was squeezed or kinked.Furthermore, a slight signs of usage in the channel were observed, but no residues were visible.Additionally, it was found that the insertion unit was not an original olympus spare part.The subject device was repaired by a third party on (b)(4) 2014.The instruction manual of this device describes a validated reprocessing procedure.The subject device was tested negative for contamination.Based on the info available, the exact cause of the bacteria detected from the patients cannot be conclusively determined, but the phenomenon is highly likely to be attributed to some causes other than the subject device.The manufacturing history was reviewed, with no irregularities related to this problem noted.If add'l info becomes available at a later time, this report will be supplemented.Please cross-reference the following reports for the associated three complaint cases: mfr reports: 8010047-2015-00052, 8010047-2015-00054,8010047-2015-00055.

• Brand Name: EVIS EXERA II BRONCHOVIDEOSCOPE
• Type of Device: OLYMPUS BF TYPE 1T180
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORPORATION; 2951 ishikawa-cho; hachioji-shi, tokyo 192- 8507; JA 192-8507
• Manufacturer Contact: hiroki moriyama ; 2951 ishikawa-cho; hachioji-shi, tokyo ; JA ; 26425177
• MDR Report Key: 4448070
• MDR Text Key: 5385237
• Report Number: 8010047-2015-00053
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BF-1T180
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other