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

Model Number URF-P6

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 04/22/2017

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has not been returned to olympus medical systems corp., but was returned to olympus (b)(4).The subject device was sent to an independent laboratory, and the culture test was conducted.As a result, the detected microorganisms were less than 1 (ufc / 100 ml) from the instrument channel.The name of microorganisms is unknown.The culture test result cleared the (b)(6) regulation.The manufacture record of the subject device was reviewed with no irregularity relating to the phenomenon.The exact cause of the event could not be determined at this moment.If additional and significant information becomes available, this report will be supplemented.

Event Description

Olympus was informed that the subject device was tested positive, when the user facility conducted a routine culture test.The name and amount of microorganisms are unknown, and it is unknown in which part of the scope the microorganisms were found.There was no report of patient infection associated with this report.

• 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
• Manufacturer Contact: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 6613723
• MDR Text Key: 76895933
• Report Number: 8010047-2017-00690
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: PK912120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 06/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-P6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2014
• 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