MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. URETERO-RENO VIDEOSCOPE

Model Number URF-V

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 in this report has not yet been returned to omsc.For evaluation.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 surveillance culturing test at the user facility, the subject scope tested (b)(6) for unspecified microbes.It was reported that the subject device was brand new and the test was conducted right after the purchase.The facility did not provide other detailed information such as the number and the type of bacteria.Other detailed information such as the reprocessing method was not provided.There was no report of infection associated with this report.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.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 microbiological testing.As a result of the testing, the sample collected from all channels of the subject device tested positive for staphylococcus coagulase negative (1 cfu /endoscope).The testing result didn¿t clear the (b)(4) guideline.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Because the testing result which was conducted by the third party laboratory didn¿t clear the (b)(4) guideline, the subject device was re-tested after disinfection several times.Following microbes were detected from the sample collected from the all channels of the subject device, and testing results didn¿t clear the french guideline.Test on (b)(6) 2018: staphylococcus coagulase negative (1cfu/endoscope).Test on (b)(6) 2018: bacillus spp.(2cfu/endoscope).The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Manufacturer Narrative

This supplemental report is being submitted to provide the device evaluation result.The insertion section of the subject device referenced in this report was returned to omsc for evaluation.The evaluation of the subject device by omsc confirmed following.There was no air leakage.The channel-opening and inside of the instrument channel were no abnormality.The exact cause of the reported event could not be conclusively determined.

• Brand Name: URETERO-RENO VIDEOSCOPE
• Type of Device: URETERO-RENO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 7395035
• MDR Text Key: 104558791
• Report Number: 8010047-2018-00576
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• PMA/PMN Number: PK072957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1