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

Model Number URF-P7

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device has not been returned to omsc but was returned to olympus (b)(4).Sent the device to a third party laboratory for microbiological testing.As a result of the testing, no microbe was detected from the sample collected from the all channels of the subject device.The testing result cleared the french 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.

Event Description

Olympus medical systems corp.(omsc) was informed that as a result of multiple microbiological testing by the user facility, following microbes were detected from the sample collected from the subject device.[first time; (b)(6) 2020] all channels: moraxella osloensis (1 cfu/100ml).[second time; (b)(6) 2020] all channels: sphingomonas paucimobilis (1 cfu/100ml), micrococcaceae (1 cfu/100ml).[third time; (b)(6) 2020] all channels: coagulase negative staphylococci (1 cfu/100ml).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 olympus medical systems corp.(omsc) for evaluation but was returned to olympus france (ofr).Ofr inspected the subject device and found partial peeling off of the adhesive at the edge og the bending rubber and looseness of the venting connector.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported phenomenon could not be conclusively determined.However, based on the ofr investigation, we presume it is unlikely that the reported phenomenon was attributed to the subject device because the microbiological test result cleared the french guideline after ofr¿s reprocessing.

• Brand Name: URETERO-RENO FIBERSCOPE
• Type of Device: URETERO-RENO FIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11235148
• MDR Text Key: 244096760
• Report Number: 8010047-2021-01922
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• PMA/PMN Number: K181451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-P7
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1