MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA LLL COLONOVIDEOSCOPE

Model Number	CF-HQ190I
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device has not been returned to olympus medical systems corp(omsc).But was returned to (b)(4) for evaluation.The evaluation at (b)(4) confirmed no irregularity in the subject device.Omsc reviewed the manufacture history of the subject device and confirmed no irregularity.The exact cause could not be determined at present.If significant additional information is received, this report will be supplemented.
Event or Problem Description
Olympus (b)(4) was informed that the fecal samples of five patients tested positive for salmonella zanzibar and all five patients experienced colonoscopy using the subject device.It was reported that the test result of the microbiological testing for the subject device at the facility did not reveal the bacteria.This is one of five reports.

• Brand Name: EVIS EXERA LLL COLONOVIDEOSCOPE
• Common Device Name: COLONOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 7047861
• Report Number: 8010047-2017-01829
• Device Sequence Number: 9964725
• Product Code: FDF
• Combination Product (Y/N): N
• PMA/510(K) Number: PK112680
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Type of Report: Initial
• Report Date (Section B): 11/21/2017

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
• Operator of Device: No Information
• Device Model Number: CF-HQ190I
• Other Device ID Number: 04953170305139
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2017
• Initial Report FDA Received Date: 11/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other