MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION EVIS EXERA II DUODENOVIDEOSCOPE

Model Number TJF-Q180V

Device Problems Device Reprocessing Problem (1091); Microbial Contamination of Device (2303)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/11/2015

Event Type  malfunction  

Event Description

Olympus medical systems corp.(omsc) was informed that klebsiella pneumoniae were detected from instrument channel, air/water channel, and distal end during a routine inspection at an off-site laboratory.There is no report of adverse event related to the detection of the bacteria.

Manufacturer Narrative

After the subject device was reprocessed at the branch dusseldorf, the subject device was returned to olympus (b)(4) for evaluation.(b)(4) has sampled the subject device, and ordered a culture test at an off-site laboratory.Based on the microbiological testing conducted at an off-site laboratory, there was no germ detected from the subject device.Based upon the evaluation of the subject device by (b)(4), it was confirmed that there were air leakage from the distal end, some dents on the c-cover, corrosion on the lg lens, discoloration of the bending rubber cementing and, some scratch inside of the instrument channel.The damages possibility occurred by handling of the facility.It is confirmed that the facility used a non-olympus automatic endoscope reprocessor and brush which are not combination equipment described in the manual of the subject device.As mentioned above, the exact cause of user's report could not be conclusively determined, however, insufficient reprocessing and inadequate maintenance could not be ruled out as a contributory factor to the reported event.This report is being submitted as a medical device report in an abundance of caution.

• Brand Name: EVIS EXERA II DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORPORATION; 2951 ishikawa-cho,; hachioji-shi; tokyo 192- 8507; JA 192-8507
• Manufacturer Contact: susumu nishina ; 2951 ishikawa-cho,; hachioji-shi,; tokyo 192-8-507 ; JA 192-8507 ; 26425177
• MDR Report Key: 4706772
• MDR Text Key: 21056210
• Report Number: 8010047-2015-00327
• Device Sequence Number: 1
• Product Code: NWB
• 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,User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: TJF-Q180V
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2012
• 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