MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE; SMALL INTESTINAL VIDEOSCOPE

Model Number SIF-Q180

Device Problem Microbial Contamination of Device (2303)

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

Event Date 01/16/2017

Event Type  malfunction  

Manufacturer Narrative

The subject device in this report has not yet been returned to omsc for evaluation.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 becomes available or if the device is returned at a later time, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that during a routine surveillance culturing at the user facility, the subject device tested positive for an unspecified microorganism.The biopsy channel of the subject device tested positive for an unspecified microorganism (2 cfu).The air/water cylinder and the suction connecter tested positive for an unspecified microorganism (70 cfu).The suction channel tested positive for an unspecified microorganism (32 cfu).There was no report of infection associated with this report.

Manufacturer Narrative

This supplemental report is being submitted to provide the device evaluation result.The subject device has not been returned to olympus medical systems corp.(omsc) but was returned to olympus (b)(4).(b)(4) sent the subject device to a third party laboratory for microbiological testing and the testing indicated no microorganisms growth for the subject device.After the completion of the microbiological testing at the third party laboratory, (b)(4)confirmed the following for the subject device: there were a lot of scratches in the biopsy channel.C-cover was extremely deformed.And (b)(4) followed up with the user facility and found the subject device had been reprocessed using a non olympus automated endoscope reprocessor model.

• Brand Name: EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE
• Type of Device: SMALL INTESTINAL VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• Manufacturer Contact: hiroki moriyama ; 2951 ishikawa-cho; hachioji-shi, tokyo-to ; 8142642517
• MDR Report Key: 6330858
• MDR Text Key: 67590404
• Report Number: 8010047-2017-00169
• Device Sequence Number: 1
• Product Code: FDA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK071254
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup

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: SIF-Q180
• Other Device ID Number: 04953170339936
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2017
• Initial Date FDA Received: 02/14/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2011
• 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