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 11/14/2017

Event Type  malfunction  

Manufacturer Narrative

The subject device has not been returned to omsc but was returned to olympus (b)(4).(b)(4) sent the subject device to a third party laboratory for additional microbiological testing.In the test, the biopsy channel, the suction channel and the air/water channel of the subject device tested positive for the following some kinds of bacteria.The biopsy channel: coagulase -negative staphylococci (4 cfu /channel).The suction channel: micrococcaceae (6 cfu /channel) and coagulase-negative staphylococci (7 cfu /channel).The air/water channel: coagulase -negative staphylococci (2 cfu /channel).The result of the additional microbiological testing by a third party laboratory didn¿t satisfy the (b)(6) guideline.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 significant additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that during a surveillance culturing at the user facility, the subject device tested positive for pseudomonas aeruginosa (>150 cfu/ 100 ml).The subject device had been reprocessed with medivator, a non olympus automated endoscope reprocessor model, using 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
• 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: 7146992
• MDR Text Key: 96239494
• Report Number: 8010047-2017-02097
• 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,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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-H190
• Other Device ID Number: 04953170305290
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/28/2017
• Initial Date FDA Received: 12/26/2017
• Supplement Dates Manufacturer Received: 02/13/2019
• Supplement Dates FDA Received: 02/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2012
• 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