MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE; SMALL INTESTINAL VIDEOSCOPE

Model Number SIF-Q180

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The subject device in this report has not been returned to omsc for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that as a result of microbiological testing by the user facility, the subject device tested positive for unspecified microbes.The user facility did not provide other detailed information such as the number and the type of microbes.Other detailed information such as the reprocessing method was not provided.There was no report of infection associated with this report.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device has not been returned to omsc but was returned to olympus deutschland gmbh (ode).Ode sent the device to a third party laboratory for microbiological testing.As a result of the testing, no microbe was detected from the sample collected from the distal end unit, the instrument channel, and the air/water channel of the subject device.The testing result cleared the german guideline.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined.If additional information becomes available, this report will be supplemented.

• Brand Name: EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE
• Type of Device: SMALL INTESTINAL VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 9508699
• MDR Text Key: 205111001
• Report Number: 8010047-2019-04519
• Device Sequence Number: 1
• Product Code: FDA
• UDI-Device Identifier: 04953170339936
• UDI-Public: 04953170339936
• Combination Product (y/n): N
• PMA/PMN Number: K071254
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 05/24/2020

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?: Yes
• Device Operator: No Information
• Device Model Number: SIF-Q180
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/04/2019
• Initial Date FDA Received: 12/22/2019
• Supplement Dates Manufacturer Received: 12/20/2019; 04/28/2020
• Supplement Dates FDA Received: 01/07/2020; 05/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1