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

Model Number GIF-HQ190

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 has not been returned to olympus medical systems corp.(omsc).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 was informed that during surveillance culturing test by the facility, the subject device tested positive twice for unspecified bacteria.The facility did not provide other detailed information such as the number and the type of bacteria, but there was no report of infection associated with this report.

Manufacturer Narrative

This supplemental report is being submitted to report additional information received from the user facility on december 15, 2017.Olympus followed up with the user facility to obtain additional information and was informed that the biopsy channel of the subject device tested positive twice (on november 7,2017 and november 22,2017) for unspecified bacteria (>20cfu).It was also informed that the biopsy channel had been brushed with olympus single use brush (model bw-422t and maj-1339) and the subject device had been reprocessed using olympus automated endoscope reprocessor model etd-3 (not available in the usa) with peracetic acid.The exact cause could not be determined at present.If significant additional information is received, this report will be supplemented.

Manufacturer Narrative

This supplemental report is submitted to correct "device product code" and "pma/510(k) number.

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 europe (b)(4).Following additional high level disinfection at olympus europe (b)(4), the subject device was send to a third party laboratory for additional microbiological testing.In the additional test, the testing indicated no microbial growth for the subject device.The evaluation by olympus europe (b)(4) confirmed that bending section rubber, angulation mechanism and distal end cover had signs of wear and tear.

• 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 ; 426425177
• MDR Report Key: 7147025
• MDR Text Key: 96235679
• Report Number: 8010047-2017-02101
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: GIF-HQ190
• Other Device ID Number: 04953170305276
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2019
• 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