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

Model Number GIF-1TQ160

Device Problem Microbial Contamination of Device (2303)

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

Event Date 11/08/2017

Event Type  malfunction  

Manufacturer Narrative

The subject device has not been returned to olympus medical systems corp.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 Description

Olympus medical systems corp.(omsc) was informed that during routine surveillance culturing test by the facility, the subject device tested positive for unspecified bacteria.The type and number of bacteria were not informed.The subject device had been reprocessed using non-olympus automated reprocessor (soluscope4) with peracetic acid.There was no report of patient infection associated with the event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device has not been returned to olympus medical systems corp.But was returned to olympus (b)(4).Following additional high level disinfection at olympus (b)(4), the subject device was sent to a third party laboratory for additional microbiological testing.In the additional test, the auxiliary channel tested positive for staphylococcus coagulase negative(1cfu/20ml) but the testing indicated no microbial growth for the other channels.The testing result cleared (b)(4) guideline.

Manufacturer Narrative

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

• Brand Name: EVIS EXERA 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 ; 426425177
• MDR Report Key: 7103633
• MDR Text Key: 95800878
• Report Number: 8010047-2017-01967
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK954451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/06/2019

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-1TQ160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/16/2017
• Initial Date FDA Received: 12/11/2017
• Supplement Dates Manufacturer Received: 12/13/2017; 02/13/2019
• Supplement Dates FDA Received: 01/08/2018; 03/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2013
• 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