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

Model Number GIF-H190

Device Problem Microbial Contamination of Device (2303)

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

Event Date 11/23/2017

Event Type  malfunction  

Manufacturer Narrative

The subject device has not been returned to omsc.Omsc reviewed the manufacturing history of the subject 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 microbiological testing by the user facility, the air/water channel of the subject device tested positive for pseudomonas putida (1cfu/channel).The test result cleared the (b)(4) guideline.The subject device had been disinfected using an olympus automated endoscope reprocessor model etd3 (not available in the u.S.) with peracetic acid.There was no report of infection associated with this report.

Manufacturer Narrative

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

• Brand Name: EVIS EXERA III 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: 7145436
• MDR Text Key: 96128907
• Report Number: 8010047-2017-02093
• 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: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/25/2019

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-H190
• 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: 06/22/2016
• 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