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

Model Number GIF-Q180

Device Problem Microbial Contamination of Device (2303)

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

Event Date 10/10/2017

Event Type  malfunction  

Manufacturer Narrative

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 (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 channels of the subject device.Omsc reviewed the manufacture history of the subject device and confirmed no irregularity.The exact cause could not be determined at present.

Event Description

Olympus medical systems corp.(omsc) was informed that during routine surveillance culturing test by the facility, the subject device continuously tested positive for several microorganism three times.On (b)(6) 2017, the biopsy channel tested positive for klebsiella variicola and escherichia coli.The air/water channel tested positive for klebsiella oxytoca and enterobacter cloacae (>100cfu/100ml: total cfu from the channels).On (b)(6) 2017, the biopsy channel tested positive for achromobacter sp., escherichia coli and klebsiella variicola (>100cfu/100ml in total).The test indicated no microbial growth for the air/water channel.On (b)(6) 2017, the biopsy channel tested positive for coagulase negative staphylococcus.The air/water channel tested positive for coagulase negative staphylococcus and pseudomonas aeruginosa (7cfu/100ml: total cfu from the channels).The facility had reprocessed the subject device using non-olympus automated endoscope reprocessor (soluscope) 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".

• Brand Name: EVIS EXERA II 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: 7023868
• MDR Text Key: 93040812
• Report Number: 8010047-2017-01754
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK100584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/26/2019

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-Q180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/16/2017
• Initial Date FDA Received: 11/13/2017
• Supplement Dates Manufacturer Received: 02/13/2019
• Supplement Dates FDA Received: 02/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2010
• 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