MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

Model Number GIF-H185

Device Problem Microbial Contamination of Device (2303)

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

Event Date 10/18/2017

Event Type  malfunction  

Manufacturer Narrative

The subject device has not been returned to omsc but was returned to olympus (b)(4) (ofr).Ofr sent this device to a third party laboratory for additional microbiological testing.As a result of additional microbiological testing by a third party laboratory, no microbe was detected from the instrument channel, suction channel and air/water channel of this device.Therefore, it cleared the (b)(4) guideline.Also, omsc reviewed the manufacturing history of this device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that as a result of routine microbiological testing by the user facility, the microbes were detected as follows, from the subject device which was reprocessed using a non-olympus automated endoscope reprocessor made by wassenburg.The user facility reported that this device was reprocessed according to the instruction manual.There was no report of infection associated with this report.<1st time> - instrument channel: 37cfu/channel(pseudomonas aeruginosa).- suction channel: 1cfu/channel(aerobic flora).<2nd time> - instrument channel: 500cfu/channel(pseudomonas aeruginosa).- suction channel: 8cfu/channel(aerobic flora).

Manufacturer Narrative

This supplemental report is submitting to correct "device product code".

• Brand Name: EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• Manufacturer Contact: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 7044349
• MDR Text Key: 93569372
• Report Number: 8010047-2017-01826
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/03/2019

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: Health Professional
• Device Model Number: GIF-H185
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/02/2017
• Initial Date FDA Received: 11/20/2017
• Supplement Dates Manufacturer Received: 02/13/2019
• Supplement Dates FDA Received: 03/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2015
• 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