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

Model Number URF-P5

Device Problems Device Reprocessing Problem (1091); Leak/Splash (1354); Contamination /Decontamination Problem (2895); Device Disinfection Or Sterilization Issue (2909)

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

Event Date 07/01/2016

Event Type  malfunction  

Manufacturer Narrative

Olympus reprocessed the subject device and the cultivation test was performed.The cultivated sample was analyzed by the (b)(6).The device was quarantined until the result was available.According to the final report of the (b)(6) on july 1, 2016, the subject device complied with 2012 design recommended criteria of (b)(6), because microorganisms which may cause health injury were not detected from the subject device.Though microorganisms which may not cause health injury were detected from the instrument channel, they were below the upper limit of the guidelines.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available at a later time, this report will be supplemented.

Event Description

The subject device has been returned to olympus due to an air leak and a probability of (b)(6) contamination.There was no patient injury reported.

• Brand Name: URETERO-RENO FIBERSCOPE
• Type of Device: URETERO-RENO FIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951; ishikawa-cho; hachioji-shi, tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: susumu nishina ; 2951; ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 6425177
• MDR Report Key: 5849147
• MDR Text Key: 51237236
• Report Number: 8010047-2016-01073
• Device Sequence Number: 1
• Product Code: FBN
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K#: K912120
• 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
• Report Date: 08/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-P5
• Device Catalogue Number: URF-P5
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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